Medtronic infusion set problems

medtronic infusion set problems The MiniMed™ Mio™ Advance infusion set works with all major insulin pump brands with luer-lock or MiniMed™ connections including Medtronic, Roche and Animas® 3. MiniMed Paradigm insulin pumps are used by diabetics to receive insulin at the proper time. July 10, 2009 -- Medtronic Inc. That you have read and are aware of our privacy policy. The MiniMed Quick-Set. A CGM glucose sensor is inserted every 7 days. Family T1 since 1985, MM Pump 2013, CGM 2015 Defective Medtronic Quick-Set Infusion Set Had an issue with a defective set earlier today. “The Medtronic MiniMed pump and infusion set at issue are both the subject of recalls. As the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets (Quick-Set™, Mio™, Mio™ 30, Sure-T™, and Silhouette™) used with Medtronic The most serious of these Medtronic insulin pump notices include recalls of Medtronic MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs. wear the same infusion set1,2 Longer set wear may lead to poor blood glucose control and more hyperglycaemic episodes3 Delaying your set change means you are 4 times more likely to have infusion site problems (itching, bruising, swelling and pain)3 More set problems, such as poor adhesion and leakage, Constant delivery blocked alarms…is the pump too sensitive to back pressure? Is there a problem with the infusion sets? You cannot get a solution from Medtronic. The component of the infusion set… was recalled by Defendant Becton Dickinson and Company on December 23, 2016. If you do not set a High Glucose Limit and do not set glucose alerts ON, then you will not get a high sensor glucose alert. Click here to view our different infusion sets Struggling to control my diabetes on day 4. box of Quick Set infusions sets, I bought in April 2004. Some infusion sets have a type of universal connector called a “Luer”, or Luer-lock. Change the infusion set every two to three days per the infusion set manufacturer's instructions. Food and Drug Administration (FDA). So I changed with the "mio infusion set" and I have no problem. S. The most popular model from Medtronic is the MiniMed Quick Set Using an infusion set longer than 3 days??? "The FDA approved on Friday a proposed trial of an insulin infusion set that can be worn for 7 days, according to a press release from Medtronic. Last month, Medtronic sent an urgent safety notification to doctors and other health care professionals warning that The set comes with a built-in inserter (yes I know the Medtronic Mio has this too), which is a one button release system, so much easier to use than the two button system. So whenever glucose levels rise for no apparent reason, checking the set is the first suggestion that most pump users offer. An infusion set delivers insulin from the pump to the body. The infusion set that attaches to your body contains a small, flexible tube that is inserted under the skin and changed every 2-3 days. Visit www. If you have any questions or concerns about Medtronic Paradigm insulin infusion sets, contact Medtronic's 24-hour helpline on 1800 777 808 (option 1). Some infusion sets have an insertion device, which is a push-button tool that inserts the set for you. htmlMiniMed Mio™ is the newest MiniM June 2013 – MiniMed Paradigm infusion sets recalled due to pump priming issues; 2009 – MiniMed Quickset infusion sets for the Paradigm pump recalled due to a manufacturing defect which resulted in misdosing; MiniMed Insulin Pump Recall Lawsuit. Most people in the diabetes community know what a pump is, but for those who don’t, I’ll give a quick overview. It is clear that Medtronic did not resolve the problem with their product that resulted in the 2013 recall. Page 125 Note: If you are using an infusion set with a needle, you do not need to fill the cannula. Select Done when the system prompts you to continue with the fill process. The CGM can be used continuously for up to 7 days before the sensor must be replaced. 16. Have any of you had similar problems? The Medtronic Diabetes eShop gives you the convenience of browsing and buying from our catalogue of insulin pump supplies, continuous glucose monitoring supplies and accessories. MiniMed Silhouette is the MiniMed infusion set which offers the most flexibility, with a variable insertion angle from 20 to 45° enabling to adjust the depth of insertion. EASIER, FASTER, HASSLE-FREE 1. The Medtronic Minimed Quick-set® infusion conveniently disconnects at the infusion site and offers a pre-attached adhesive for a discreet, low profile design. For patients with an infusion set that is in and working, nothing needs to be done, said Annette Bruls, president of Medtronic’s diabetes service and solutions business. I had many many issues with the cannula not going in correctly,no delivery problems and soreness. The type of set shipped with a new pump is usually one manufactured by the pump company and this set may or may not be the best choice. At the time my Bg was about 150, a little high PP from lunch. The MMT numbers may change if other compatible infusion sets become available. MiniMed® Quick-set™ Infusion Sets. I'm quite a lean guy and was using the quick sets from MEdtronic which get inserted at 90 degree angle - so straight in. Device Problem Inaccurate Delivery (2339) Patient Problems Hyperglycemia (1905); Hypoglycemia (1912) Event Date 03/01/2012: Event Type Malfunction Event Description I am a diabetic user of the medtronic inc revel insulin pump and sensor. issued a similar recall for approximately three million Quick-set infusion sets used with its MiniMed Paradigm insulin pumps, due to a manufacturing defect that could Medtronic recently presented data on its 7-day infusion set, which can be worn twice as long as current sets that are okayed for a max of 3 days. ” I had been using the Quick Set (without plus)infusion sets for about 9 months combined with the Medtronic Minimed Paradigm 511E insulin pump. Contact the Medtronic infusion set lawyers at Saiontz & Kirk, P. The order is over a week late and Medtronic apparantly do not hold any stock in the UK, so it comes from Belgium. to review your potential claim. Gout or chronic kidney disease resulting in uric acid levels greater than 59 mg/dL. Medtronic might be happier to supply infusion sets because they actively manufacture them so they just happen to be the right people to call about infusion sets as well. The infusion set is a little smaller than the quickset with a larger adhesive area, which is a huge plus. A wrongful death lawsuit has been filed against Medtronic by a woman whose daughter allegedly died due to problems with Medtronic Paradigm Quick-Set Infusion sets used with the MiniMed insulin pump. A defect discovered in the tubing in these devices caused the manufacturer, Medtronic, to recall approximately 60,000 tubes that may have had problems delivering the correct amount of insulin due to air pressure issues. The surge in complaints stems from kinked cannulas that can interrupt the flow of insulin, leading to elevated blood sugar levels. I have been using the Medtronic pump for 10 years with the QuickSet infusion set and started developing a rash the same as you described about 5 years ago (I suspect they may have changed the4 adhesive. 6358. Call 24-Hour HelpLine at 1-800-284-4416, option 1 and 1 Troubleshooting High Blood Glucose After Set Change Medtronic is warning its customers that there has been a “higher than expected number of reported complaints” of its MiniMed Pro-set infusion sets. Please note, the Sure T-infusion set is a steel cannula and therefore does not have a removable introducer needle. Start over with a new reservoir and infusion set. Medtronic offers the widest range of infusion sets. The set will stay in place for two to three days, then you’ll rotate your infusion site and insert a A patient guide explaining how insulin and cannulas are changed on the Medtronic 640G. The MiniMed ™ Silhouette ™ infusion set is a soft cannula infusion set that can be inserted at a variety of angles. Two days later when I change my infusion set, I have the flexibility to use a VariSoft, a TruSteel, a Medtronic Silhouette or Sure-T, or an Animas Comfort or Contact Detach. The pump does not deliver insulin in the prescribed manner it is designed. I have now run out. medtronic-diabetes. Laura Cleverly. ” [2] This time, the recall notice specifically identifies the vent in the connector as the source of the problem and indicates that infusion sets sold prior to April 2017 may have contained this Medtronic MiniMed Infusion Sets: Global Recall of Specific Sets People who have been using the Diabetes Infusion Set manufactured by Medtronics may have suffered a serious medical emergency directly related to the over-delivery of insulin. May 19, 2004 -- A medical device maker is recalling an insulin infusion kit used by people with diabetes due to potentially dangerous problems. Clear advice that demonstrates how to insert a cannula for the Medtronic Minimed 640G. 5 units 23"32"43" 90° Clear MiniMed ™ Silhouette ™ Infusion Set. D. Of course I said yes. *MiniMed™ Quick-set™ infusion set shown in illustration. The problem is that a vent membrane in some of the sets could be blocked by fluid. Perhaps, since they use the same infusion sets, I'd be able to do some neat comparisons. I am using a Medtronic MiniMed Paradigm Quick Set infusion set, 6mm cannula. Therefore, only sets made for use with this pump can be In this video, we will show you how to insert a new Autosoft 90 Infusion Set. Infusion sets continually leak. It even hurts to put the least amount of pressure on the device. But in June 2013, Medtronic had issued an Urgent Medical Device The latest innovation, MiniMed™ Mio™ 30 infusion set, is a hugely beneficial addition to our portfolio, offering diabetes patients improved flexibility, greater comfort and angled insertion. I have now run out. There has been a slight increase in reports of cases where the needles of these infusion sets have broken during use. Problems with Medtronic Supplies and Customer Service Kevin211 I have been experiencing alot of problems with Quick-Set Paradigm Sets with lot # 9200549 and/or with reservoirs lot # H7565318 and have not had any luck in having Medtronic resolve these issues. Nevertheless, Medtronic redesigned the P-Cap to eliminate the problem and is offering to replace older infusion devices with new ones, free of charge. Check your site regularly for irritation, redness, swelling or bleeding. Do I have a Case? Infusion set or tubing issue? Disconnect at your site and purge the air bubbles from the tubing using the fill cannula or prime feature. Medtronic has faced thousands of lawsuits over injuries caused by its medication pumps in the past. It goes into sites (areas) on the patient’s body, similar to where they would usually inject insulin. The order is over a week late and Medtronic apparantly do not hold any stock in the UK, so it comes from Belgium. Medical devices such as DePuy’s metal-on-metal hip implants, Bayer’s Essure birth control device, and Medtronic’s Infusion insulin pump have been linked to severe complications. D. **Some infusion sets do not use a soft cannula but have a small needle that remains in your subcutaneous tissue. One of the down sides to pumps is that if the occasional set bends, the insulin can't flow easily and you are absolutely correct that the only way you can know is that blood sugar levels go up and stay up. INFUSION SETS Most insulin pumps require an infusion set to move the insulin in the device to your body. ” Lawsuits related to insulin pumps often blame malfunctions for causing injuries or deaths. For patients with an infusion set that is in and working, nothing needs to be done, said Annette Bruls, president of Medtronic’s diabetes service and solutions business. The current manufactured infusion sets, available since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. Medtronic did have a problem with the Lot 8 infusion sets, but were very quick to handle it IMHO…they could have been like a good many other companies with a wait and see attitude, but they recalled the sets also telling you exactly why they were recalled, and replaced them with a working set sending 1 box (10 count) out to their patients until they were all caught up. This flexibility combined with Silhouette's very slim profile makes it very comfortable. co. Major advantages of using an infusion set include a more flexible lifestyle, predictable and precise insulin delivery, and improved blood glucose control. Some time ago I started to wonder whether this was affecting my control at all: was that 4th day making my average blood sugar go up? I had the data, so I set out to experiment. After using the Medtronic CGM for 2 weeks I can understand why it cannot be used to determine how much insulin to dose. Defective Medtronic Quick-Set Infusion Set D. I have had my 670g for about a year and have had constant issues with the infusion sets leaking, every time I have to call support and get a new one shipped only to have the problem happen again and again, there was one week where I had to get three sets replaced. If insulin or any other liquid has gotten on the top of the reservoir or inside the tubing connector, discard both and start over with a new reservoir and infusion set. It could also lead to death. In the event the above website is not accessible or for additional questions, please call 1-800-345-8139 at Medtronic Diabetes 24- hours a day. 5 million Medtronic MimiMed Infusion sets. The recall explained a manufacturing defect of the tubing used in the Quick-Set? Medtronic Guardian™ Link (1) Medtronic HV-R® Fenestrated Screw Cement (1) Medtronic MiniLink® (1) Medtronic MiniMed 530G (1) Medtronic MiniMed Pro-Set Infusion Set, Luer Connection 24in (2) Medtronic MiniMed Pro-Set Infusion Set, Luer Connection 42in (2) Since the CGM sensor and infusion set are now connected, you are forced to change them both out at the same time every three days. Many of such devices have been recalled by the U. But still I have the problem that every time I try to insert the infusion set in my upper legs the cannula gets bent. Considering it was a problem and possibly kinked, I started a new infusion set at 10 am this morning - nearly 12 hours ago. Medtronic instructed customers that they will replace all reservoirs from the affected lots at no cost. Your report will contribute to the TGA's monitoring of these products. Medtronic infusion sets utilize a Safe Needle Disposal System created to prevent accidental needlesticks during disposal. For a better insulin absorption, and to help avoid insulin degradation and infusion set occlusion, you should change your infusion set regularly. Good Luck to you. Medtronic determined that the vent membrane, a component in the recalled infusion sets, could be blocked by fluid during the process of priming/fill-tubing. uk/product-information/infusion-sets/index/mio. The insulin moves from the pump via a tube that is connected to your skin through a cannula. Due to a history of problems with the MiniMed Insulin Pumps, Medtronic has faced multiple lawsuits for injuries caused by the devices. Note: Always refer to your infusion set user guide for instructions on inserting an infusion set. Defective Medtronic Quick-set Infusion Set. Medtronic ranks 135 of 641 in Medical Supplies and Equipment category. Starting at a 10% basal rate my blood sugars went up instantly. Change your infusion set every two to three days. The company is asking patients to contact its 24-Hour Help Line at (800) MINIMED (1-800-646-4633) to exchange any unused Quick-set Plus infusion sets for replacement sets available currently from Medtronic. MiniMed Quick-set ®: Comfort and ease MiniMed Quick-set ® is a popular MiniMed infusion set, combining great comfort and ease of use. On day four things changed dramatically. " That would cause so much trouble for me. Medtronic has recently observed a new trend in customer reports related to potential over-delivery of insulin shortly after an infusion set change. This can cause the adhesive to break contact with the skin and could result in the cannula coming free. Using the system does not completely replace fingersticks, but you will not need to take a BG just to know your glucose level. For example, in sharp contrast to Medtronic’s Website, are statements from a June 1, 2009, letter from the United States Food and Drug Administration (“FDA”) to William A. The week of April 17, 2013, the FDA issued a Class II recall of the Medtronic MiniMed Paradigm Insulin Infusion Pump, intended for use to deliver insulin to people with diabetes. Defective Medtronic Quick-Set Infusion Set D. Threshold Suspend . The most serious of these Medtronic insulin pump notices include recalls of Medtronic MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs. Have any of you had similar problems? When I experience the pain, I know that I will receive a "no delivery" notice when I attempted my next meal bolus. In most cases, even though products are labeled under different names, they are identical infusion sets. Infusion Sets Support | Medtronic Diabetes Toggle high contrast MEDTRONIC INFUSION SET RECALL LAWYERS If you, a friend or family member have experienced problems with a Medtronic MiniMed insulin pump resulting in serious injury after using recalled Lot 8 infusion sets, financial compensation may be available. S. ” Lawsuits related to insulin pumps often blame malfunctions for causing injuries or deaths. ” Id. If I use an infusion set more than three days, the insulin absorption is not as good. 25. Infusion sets - what do you recommend? (4 replies) why 3 days (10 replies) Square/dual wave (2 replies) Remote control for 530G? (10 replies) Manual Priming Problems (10 replies) 530G - MySentry Compatibility (2 replies) Medtronic, Covidien in Advanced Talks to Combine (2 replies) No Delivery (25 replies) Started New 530G Pump (7 replies) Motor People who use an infusion set for longer than three days are four times more likely to experience site irritations1. Clear advice that demonstrates how to insert a cannula for the Medtronic Minimed 640G. Medtronic Overview. Infusion sets connect an insulin pump to the body of a person with type-2 diabetes. People using MiniMed Infusion Sets still need to check their blood glucose levels throughout the day. The soft cannula Dispose of the infusion set and introducer Indications for use must always be completely inserted to needle safely, in a sharps container, after a receive the full amount of medication. I started using Tagaderm (3M) as a barrier between my skin and the infusion set and saw improvement for a couple of years. The On September 11, 2017, Medtronic announced yet another recall of “specific lots of infusion sets used with all models of Medtronic insulin pumps. The problem caused an overdelivery of insulin in some cases. Infusion set problem (See Tips on infusion sets and sites) Site problem; Air in tubing (resulting in missed insulin) Extended pump suspension or disconnection (for more than one to two hours) Pump malfunction; Insulin leakage (at insertion site or infusion set connection site) Illness or infection; Vomiting or dehydration; Severe emotional stress For patients with an infusion set that is in and working, nothing needs to be done, said Annette Bruls, president of Medtronic’s diabetes service and solutions business. Unfortunately, past recalls and problems associated with Medtronic infusion sets did not result in Medtronic Insulin Pump Lot 8 Infusion Set Problems Following the Medtronic recall for Lot 8 Quick-Set infusion sets used with the MiniMed Paradigm insulin pump, it has become clear that the defective sets have caused a number of problems for diabetics. I changed my set around 2pm today. The problem caused an overdelivery of insulin in some cases. An all-in-one infusion set with integrated serter – delivering convenience on the go. Risks related to serter use General risks with serter use may include skin infection around the area where the serter is used. It could be used by patients, carers or health care professionals. Flexible tubing connects to your pump reservoir, shuttling the insulin from your pump to a needle or cannula secured beneath your skin. In the medtronic vs tandem debate it's a little unfair to count points against a company that can not replacing a product that isn't made by their company. Medtronic, Inc. An infusion set includes a thin tube that goes from the reservoir to the infusion site on the patient’s body. In the medtronic vs tandem debate it's a little unfair to count points against a company that can not replacing a product that isn't made by their company. Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump's reservoir compartment. Page 9: Warranty E N G L I S H insulin. but ok. At the time my Bg was about 150, a little high PP from lunch. I've always changed my infusion set (Medtronic Silhouette) every 4 days, though the official recommendation is 3 days. This of course means that the Medtronic CGM would go from 6-day The Medtronic MiniMed system includes the Medtronic MiniMed pump, reservoir syringe and infusion set. Minimed Distr Center: MMT396, Minimed Distr Center - MMT396 - Quick-Set 43 9 mm Infusion Set, Quick-Set 43 9 mm Infusion Set But 2013′s recalls included one on the most serious level concerning the Medtronic MiniMed Paradigm insulin infusion set, with the FDA noting that “under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin. Please Unlike Pamela and Gary, Medtronic knew about the infusion set’s risk. Medtronic might be happier to supply infusion sets because they actively manufacture them so they just happen to be the right people to call about infusion sets as well. All MiniMed™ infusion sets tubing and reservoirs are designed with a unique MiniMed™ connection for a more secure insulin delivery. Skin Reaction To Infusion Sets (2 replies) "No Delivery" issues (3 replies) Need help with infusion sets, infusion sites and insulin absorbtion (22 replies) Potential Road Trip Disaster (8 replies) Medtronic Reservoir's (4 replies) Infusion set/reservoir change (18 replies) Discoloration of tubing (2 replies) Medtronic Minimed Infusion Sets (0 MiniMed Quick-set® Infusion Sets. The overall rating of the company is 1. It is the best Late in the day Friday, Medtronic announced that approximately 60,000 Quick-set infusion sets used with the Medtronic MiniMed Paradigm insulin pumps could be defective and not work properly. The pump does not deliver insulin in the prescribed manner it is designed. Infusion sets coming loose is a relatively common problem that can occur if sweat is able to gather at your infusion site. Very frustrating. Consult a physician immediately if you experience significant pain or if you suspect that the site is infected. Medtronic offers the widest range of infusion sets. Medtronic will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new These Medtronic infusion kits offer customization with varying tubing lengths and a soft, tapered plastic cannula. Some users suffered hypoglycemic or hyperglycemic events after using their sets, which in some cases, has led to coma and seizures. Insertion of a glucose sensor may cause bleeding or irritation at the insertion site. We challenge ourselves and each other to make tomorrow better than yesterday. Unfortunately, Medtronic dismissed these warnings and discontinued the old Quick-Set infusion sets in December and forced pump users to the new Quick-Set Plus and all of it's engineering defects. Device Problem Inaccurate Delivery (2339) Patient Problems Hyperglycemia (1905); Hypoglycemia (1912) Event Date 03/01/2012: Event Type Malfunction Event Description I am a diabetic user of the medtronic inc revel insulin pump and sensor. Anyone have similar issues? If so, any suggestions would be greatly I'm hoping the combined pressure of Medtronic, Dexcom, Tandem, and whoever else push the ball along in the next 9 months or so, and I won't need to go that route, but as the time gets closer, I'm preparing myself. There are no parts to put together, no intimidating or visible needle, and the device can be used with one hand – a win for kids, elderly people, and those who wear pump sets on Medtronic MiniMed Sure-T Infusion Sets are uniquely designed to provide enhanced security for continuous insulin delivery. Available in either 6mm or 9mm soft cannula. Medtronic Paradigm MiniMed Infusion Pumps. It’s also suitable for pregnant women from the end of the second trimester onwards, when the abdominal tissue begins to tighten. Read “Dexcom recalls G4 and G5 CGMs. Hi, I had pain with Medtronic "quick set" every time I tried to insert the infusion set in the abdomen. Usage Information: The mio® infusion set is Medtronic's all-in-one design, combining the insertion device with the infusion set for the ultimate convenience. Some infusion sets have a type of universal connector called a “Luer”, or Luer-lock. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. This recall has been classified as a Class I recall, which is the most serious type of recall that can be issued. It comes with a new Enlite Serter that puts the sensor in at a 90-degree angle while hiding the needle from the wearer. My insulin pump indicated that there was no delivery. The sensor glucose number is higher than or equal to your high glucose limit. If your pump uses this type of connection, you will have the greatest breadth and depth of options of infusion sets to choose from. Infusion set problems, unfortunately, cause far more hyperglycemia for those whose glucose levels are highest. Medtronic marketed the subject infusion sets without fixing the problem, resulting in another recall for the same defect in 2017. My first reaction was “what if I lose it, or forget it when I travel?” “Oh, don’t worry you can always insert the infusion set without the inserter,” she said. is voluntarily recalling Lot 8 of its Quick-set infusion sets, which deliver insulin from MiniMed Paradigm insulin pumps to diabetes patients. If someone you care for uses one of these infusion sets, ensure they are aware of this issue. Its soft cannula, hypoallergenic tape and ease of insertion with the Quick-serter® device, even in hard-to-reach areas, makes it a great choice for children and adults of average to large build. Medtronic issued a Class I recall of their MiniMed Quick-set® Paradigm Infusion Insulin pump on June 29, 2009. The following table lists the compatible infusion sets. The launch expands Medtronic’s existing MiniMed portfolio of infusion sets along with simplifying diabetes management. Customers can also report adverse events When I start a new cartridge on my t:slim, I use a Tandem infusion set (VariSoft or TruSteel) and the Tandem tubing that comes with that set. Medtronic PLC, a medical device company, is based in Ireland and one of the largest medical device manufacturers in the world, issue a recall for infusion sets used with its insulin pumps in September 2017. Its kink-free steel needle, the thinnest available in the MiniMed portfolio, combined with an extra disconnection site 10cm away from the infusion site provides extra security against clogging and dislodging. Having said all this, my doctor, my nurse, the Medtronic "helper", none of these have any advice. A U. The company indicated that it has determined that the vent membrane in the recalled MiniMed infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing, according The MiniMed™ Silhouette™ infusion set is a soft cannula infusion set that can be inserted at a variety of angles. 3 units 18"23"32"43" 90° Clear MiniMed™ Quick-serter™ MiniMed™ Quick-set™ infusion set Soft Cannula25 gauge9 mm 0. Out of the millions of infusions sets sold every year, the reported incidence rate requiring medical assistance related to this issue is less than 1 in every 2 million infusion sets. • The Medtronic’s MiniMed Paradigm® pump is an example of a pump that uses a proprietary infusion set— the connection is not a universal luer-lock fitting. The core part of this insulin delivery system is the MiniMed™ connection is patented*, unique and on every infusion set. Consumers and health professionals are encouraged to report problems with medical devices. MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus . It's nice to see/hear from a patient about how this happens in the real world. 15. I changed my set around 2pm today. Ideal for individuals who are lean or live an active lifestyle, the MiniMed ™ Silhouette ™ infusion set offers comfort and flexibility by allowing you to choose your insertion angle. S. When i removed the set from my body, blood gushed out of the opening, and i continued to bleed for several minutes. The t:90® Infusion Set is a 90-degree soft set that uses an integrated, disposa Infusion site failure is a common cause of unexplained highs. They also switched infusion set manufacturers - so the old manufacturer of the original Quick-Set shut down their plant. Medtronic Knew About the Device’s Risks. If your pump uses this type of connection, you will have the greatest breadth and depth of options of infusion sets to choose from. Skin Reaction To Infusion Sets (2 replies) "No Delivery" issues (3 replies) Need help with infusion sets, infusion sites and insulin absorbtion (22 replies) Potential Road Trip Disaster (8 replies) Medtronic Reservoir's (4 replies) Infusion set/reservoir change (18 replies) Discoloration of tubing (2 replies) Medtronic Minimed Infusion Sets (0 Integrated ‘all-in-one’ infusion set and insertion device • Easy - at-site disconnection with a press and pull motion • Paricctal - Rigid box Not all patients are the same and the different infusion sets can be used to respond to specific needs. Having more than one infusion set failure a month raises the A1c. Page 37 • Infusion sets–Contact a healthcare professional for help in choosing a Medtronic Diabetes infusion set. • Infusion sets — Medtronic Diabetes provides a variety of Paradigm-compatible infusion sets to fit your needs. Major advantages of using an infusion set include a more flexible lifestyle, predictable and precise insulin delivery, and improved blood glucose control. Medtronic says it has fixed the problem and patients can use the devices that were made from April on. The most popular model from Medtronic is the MiniMed Quick Set This item: Medtronic Quick Serter Infusion Set Insertion System $61. wear the same infusion set1,2 Longer set wear may lead to poor blood glucose control and more hyperglycaemic episodes3 Delaying your set change means you are 4 times more likely to have infusion site problems (itching, bruising, swelling and pain)3 More set problems, such as poor adhesion and leakage, On September 11, 2017, Medtronic announced a recall of “specific lots of infusion sets used with all models of Medtronic insulin pumps. 1 See full list on medtronic. Medtronic issued a MiniMed Paradigm infusion set recall in June 2013, because fluid could get into vents, preventing the pump from priming properly, which could cause severe or even fatal health problems for diabetics. Between June 2013 and May 2014, Medtronic received 750 complaints related to the same infusion sets, according to a deposition The problem is a defective vent membrane that can become blocked by fluid build-up when the pump is primed after an infusion set change is made. I ended up getting a new pump out of that and this new one has done the same thing once. pump is intended for use with the Medtronic MiniMed reservoir syringe, Model 103. Step by step guide to inserting Mio infusion set (Medtronic). " 2009 – MiniMed Quickset infusion sets for the Paradigm pump recalled due to a manufacturing defect that had resulted in dosing errors; Filing a MiniMed Insulin Pump Recall Lawsuit. has experienced an issue with the use of a Medtronic infusion set, please report it to the 24-hour helpline at +1-800-204-7616. 90-degree insertion. Medtronic asked me if I wanted to test their new Infusion Set, the Mio Advance. Because the safety of our customers is our top priority, Medtronic, in consultation with the Therapeutic Goods Administration (TGA) and Medsafe, is initiating a recall for specific Lot Numbers of infusion sets used with Medtronic insulin pumps (TGA Recall Identification # RC-2017-RN-01182-1) and Medsafe Reference # 21954). No matter how hard I pushed the pedals, the injected insulin didn’t work anymore. The FDA announced today that it has issued a recall of Medtronic MiniMed 600 Series insulin pumps as a result of problems reported with incorrect insulin dosing. Ti'sMom, Sep 15, 2013 #5. Medtronic PLC Issues Insulin Infusion Set Recall Amid Hypoglycemia Fears. 4 5 1 2 1. An infusion set is a thin plastic tube used to deliver insulin from an insulin pump to a diabetes patient, and is typically replaced by the patient every three days. but ok. The insulin pump plays 4 consecutive tones, in rising pitch, if an audible beep has been selected as the alert type. Medtronic pumps uses a proprietary infusion set connector that was specifically designed to work with their own pump reservoir. It is what makes this an exciting and rewarding place to be. Michael Stellato of Orlando, Florida, filed a lawsuit against Medtronic in 2019 claiming that one of the recalled infusion sets caused his wife’s death. Since I started pumping last year, I've been using the Medtronic QuickSet Infusion Sets, and I've had issues with kinked cannulas from day one! I thought it was my fault because of infusion sites or not injecting them properly, but after finally getting fed up and doing a little research, I realized that many people have had the same issue with the QuickSets. Keywords: how to, Medtronic, MiniMed 640G, opinion, peer, tutorial, technology, infusion set, set change, cannula change, insulin pump, everydayupsanddowns, MM640G The Class I recall involves Medtronic's MiniMed Paradigm Insulin Infusion Sets. The recall applied to specific lots of Medtronic MiniMed Quick-Set Paradigm Infusion Sets. It could be used by patients, carers or health care professionals. Set failures can be hard to recognize. Comparing Infusion Sets Infusion Set Cannula CannulaFill Amount Tubing Length Insertion Angle At SiteDisconnect Compatible with All Major Pumps Colors Insertion Device(Optional) MiniMed™ Quick-set™ infusion set Soft Cannula25 gauge6 mm 0. 6 and consumers are mostly dissatisfied. ^Components sold separately. Device Problem Loose or Intermittent Connection (1371) Patient Problem No Information (3190) Event Type Malfunction Event Description The comfort infusion set made by unomedical and distributed in the u. A. If the These problems have resulted in a number of serious injuries, including some hospitalizations. Shop if you need to place an order, get a sensor or belt clip replacement, or check the status of your supply order. Take the Medtronic infusion set linked to Pamela’s death. Reason for Recall: Medtronic is taking this action for the Medtronic MiniMed Paradigm Insulin Infusion Sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of the tubing connector. Yesterday my BG was between 260 Find troubleshooting tips, user guides, warranties, and infusion set comparison and changing information. I also like the way the tubing attaches to the set (see pic) Compared to the Spring Universal infusion set, the Mio is larger, less sturdy and because of the two fingers needed to insert, less comfortable to use. In January, Medtronic sent a one-page letter to about 500 customers taking part in the limited launch of the new MiniMed Pro-set pump infusion set with BD’s FlowSmart technology. Medtronic today The incidence of reported problems related to the P-Cap has been very rare (1-2 per million infusion sets). Antiseptic solutions and skin-prep wipes are available to purchase online to prepare the skin and help tape stick better. The website is also the most efficient way to exchange Lot 8 Quick-set infusion sets and/or place new supply orders. Step by step guide to inserting Mio infusion set (Medtronic). During the week of April 17, 2013, the FDA issued a Class II recall of certain models of the Medtronic MiniMed Paradigm Insulin Infusion Pump, intended for use to deliver insulin to people with diabetes. Replace the infusion set every 48–72 hours, or more frequently per your healthcare professional’s instructions. Heart Pump Failure Could Lead to Serious Health Problems According to Medtronic’s Field Safety Notice, pump stoppage could worsen symptoms of heart failure, including dizziness, weakness, anxiety, loss of consciousness and nausea. Scar tissue can begin to form. I ended up getting a new pump out of that and this new one has done the same thing once. Medtronic marketed the subject infusion sets without fixing the problem, resulting in another recall for the same defect in 2017. Lol We haven't had any problems as of yet and we've been pumping since December 2012. Medtronic MiniMed also provides a variety of How: infusion sets to appeal to different types of About Medtronic Together, we can change healthcare worldwide. When the Medtronic sales rep, Karen, gave me the pump and explained the different parts of the set, she pulled out the inserter and showed me how it worked. Medtronic Infusion Set users have experienced complications with their devices that have led to health problems. After switching my infusion set, I bolused The mio infusion set is Medtronic's all-in-one design, combining the insertion device with the infusion set for the ultimate convenience. On day four things changed dramatically. The clear tape is made to comfortably adhere to your skin while also being non-irritating and less painful during the removal process. Hi All, I'm a Medtronic pump user and am having a problem obtaining my most recent canula supplies. Medtronic pumps uses a proprietary infusion set connector that was specifically designed to work with their own pump reservoir. S. The Medtronic MiniMed Where: Main Menu on the BASAL RATE screen. There is the Quick-Set, the Silhouette, the Polyfi, the Easy-Set and Soft-Set. To insert a new pump set, users simply peel off the adhesive, remove the disconnect cover, place the set on the desired infusion site, and press the button to insert. Too much insulin may cause hypoglycemia. announced the nationwide recall Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change. Device Problem Loose or Intermittent Connection (1371) Patient Problem No Information (3190) Event Type Malfunction Event Description The comfort infusion set made by unomedical and distributed in the u. Quick-set is a popular MiniMed infusion set, combining great comfort and ease of use. Serious injury and death, from potentially defective or malfunctioning parts of the device , are being reported to the FDA. I swear that on the days I need to change out an infusion set, my BG readings will be very, very high. Contact your healthcare professional for help in choosing an infusion set that fits your needs. The removed infusion set looked fine - not kinked. This all-in-one infusion set offers convenience for active individuals. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. If this occurs it can temporarily block the vents that allow the pump to properly prime. Starting at a 10% basal rate my blood sugars went up instantly. Medtronic Announces Recall Of Diabetes Infusion Sets. I've been variously told that it might be stuck in customs Medtronic Infusion Sets. Medtronic infusion set (lot 9201896) had been in my body for about two days. If insulin continues to drip or squirt from the infusion set cannula after priming/fill tubing has been completed, do not insert. Medtronic has become aware of reports of potential over-delivery of insulin shortly after an infusion set change. After calling customer support, i was instructed to remove the infusion set. Fortunately, there are many alternatives to choose from. Medtronic initiated a global recall of specific lots of its MiniMed infusion sets, which are used with all models of Medtronic insulin pumps. ” Unfortunately, these warnings came too late for the plaintiff’s wife. A design update in April 2017 corrected the problem but some patients still have lots of defective infusion sets. Problems with Medtronic Supplies and Customer Service Kevin211 I have been experiencing alot of problems with Quick-Set Paradigm Sets with lot # 9200549 and/or with reservoirs lot # H7565318 and have not had any luck in having Medtronic resolve these issues. I’ve had it for about two weeks now and have done 4 site changes so I can tell you a little something about it and compare it to the Quick-set which I usually use. I swear that on the days I need to change out an infusion set, my BG readings will be very, very high. The inserter mechanism is above the adhesive so you first stick the infusion set where you want it and then you release the needle. Available in a variety of configurations and colors to match your personal body type, preferences, and lifestyle. A Class II recall is an immediate threat level recall and identifies products that might cause a temporary health problem. If a customer in the U. No single set works well for everyone, so choosing an infusion set can be difficult. For patients with an infusion set that is in and working, nothing needs to be done, said Annette Bruls, president of Medtronic’s diabetes service and solutions business. The company claimed that the situation stemmed from user error. There was a problem filtering reviews right now. The recalls are related to problems with a component of these sets that may cause low blood sugar in patients, according to Explanation of the Issue Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Pump wearers often change their infusion set and site any time they encounter unexplained high glucose readings. The Medtronic CGM is NOT certified so you still always need to do a finger poke prior giving a bolus insulin dose. An Urgent Medical Device Recall notice was sent to customers on July 3, 2013, who purchased the Medtronic Paradigm Reservoirs MMT-326A and MMT-332A. By (b)(4) should not be used with the medtronic 508 insulin pump. Also if you are using Silhouette sets, what length cannula are you using? Because you have a slim body, you might want to consider the 13mm length cannula. S. On June 7, Medtronic notified both users and clinicians about the possible consequences of insulin or some other liquid coming into contact with a component that connects the infusion set with a 26. 90-degree insertion Available in a variety of configurations and colours to match your personal body type, preferences, and lifestyle Available in either 6mm or 9mm soft cannula Page 124 Medtronic Diabetes offers a variety of infusion sets for your pump. Medtronic stated in a press release that when the infusion sets become blocked, the malfunction can “lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Infusion sets coming loose . The letter detailed how Medtronic received a “higher than expected” number of complaints related to kinked cannulas and elevated blood glucose levels. Medtronic recently discovered that approximately two percent of "Lot 8" Quick-set infusion sets (which represents approximately 60,000 infusion sets out of an estimated 3 million All MiniMed™ infusion sets and reservoirs work as a system with the pump by providing a unique interface designed for a more secure fit than standard luer connection. Test your blood glucose level to make sure the problem is corrected. That Medtronic stores information, including personal health information, on systems located outside of Canada. Family T1 since 1985, MM Pump 2013, CGM 2015 Defective Medtronic Quick-Set Infusion Set Had an issue with a defective set earlier today. People with more severe heart failure could have worse symptoms. June 2019 The FDA issues another Medtronic MiniMed Insulin Pump recall for the MiniMed 508 pump and the MiniMed Paradigm series due to cybersecurity flaws which make them hackable. Medtronic MiniMed infusion sets go with the Veo and Paradigm pumps As one of the original suppliers in the pump sector, the Medtronic range of insulin sets is comprehensive. Medtronic Inc. The Medtronic Minimed Paradigm 515 pump (RF receiver), Silhouette infusion set, and UltraLink blood sugar meter (RF transmitter). The cannula is inserted with a small needle that is removed after it is in place 7 . But then there occured many problems with a 10 p. No problem with the old pump except when the screw mechanism failed. A Medtronic MiniMed insulin pump, for example, carries about 200 units of fast-acting insulin in a machine about the size of an early pager. The company estimated that roughly 60,000 out of 3 million infusion sets could be affected. A federal judge has decided a lawsuit over problems with a Medtronic Synchromed II Infusion Pump can proceed forward, after rejecting an attempt by the manufacturer to dismiss the claim. Only 1 left in stock - order soon. Past attempts at infusion set Hi All, I'm a Medtronic pump user and am having a problem obtaining my most recent canula supplies. NEW DELHI: Dublin-headquartered medical device firm Medtronic is voluntarily recalling specific lots of its ‘MiniMed’ infusion sets used with all models of its insulin pumps globally, including 5,000 sets from India. Thousands of diabetic patients use this device to monitor their blood glucose levels and assist them in the control of their glucose levels by delivering doses of insulin on a pre-determined schedule. Medtronic is recalling several lots of infusion sets used with its MiniMed insulin pumps, due to a risk of accidental overdose associated with design problems. The complaint says Wendy Stellato tried to drive home from work after the kit malfunctioned. Problem with Mini-Med Infusion Sets. In 2009, Medtronic Inc. The recall letter informed the customers of the problems and the actions to be taken. People using MiniMed Infusion Sets still need to check their blood glucose levels throughout the day. No matter how hard I pushed the pedals, the injected insulin didn’t work anymore. On November 18, 2017, the FDA announced a Class 2 device recall for over 9. Medtronic was first mentioned on PissedConsumer on Jan 11, 2011 and since then this brand received 359 reviews. The differences between the MiniMed™ Infusion Sets will be explained later in the brochure. There is also a webpage on the Medtronic website, Comparing Infusion Sets | Medtronic Diabetes - that compare the different infusion sets they offer. The website is also the most efficient way to exchangeLot 8 Quick-set infusion sets and/or place new supply orders. Medtronic plc MDT recently launched an easy-to-use insulin infusion set, MiniMed Mio Advance, for the insulin-dependent diabetic patients in the United States. Change the infusion set immediately if you have unexplained high readings or moderate or large ketones. But 2013's recalls included one on the most serious level concerning the Medtronic MiniMed Paradigm insulin infusion set, with the FDA noting that "under certain conditions, the infusion set may Medtronic Australasia has written to MiniMed Silhouette or MiniMed Sure-T infusion set users to notify them of this issue and the precautions they need to take to keep using the sets. According to CR, Medtronic, the maker of the infusion set that allegedly caused this patient’s death, knew about the dangers its device presents. Its soft cannula, hypoallergenic tape and ease of insertion with the Quick-serter ® device, even in hard-to-reach areas, makes it a great choice for children and adults of average to large build. com Medtronic also continues to monitor the safety of the SynchroMed Infusion System, initiating and supporting studies involving the accuracy, safety and performance of the System. MINIMED™ MIO™ 30 INFUSION SET . Nevertheless, Medtronic redesigned the P-Cap to eliminate the problem and is offering to replace older infusion devices with new ones, free of charge. This can lead to over-delivery of insulin. pivotal trial is ongoing and this new Tandem infusion sets are made by Unomedical, the same company that manufactures infusion sets sold by other insulin pump companies. In the event the above website is not accessible or for additional questions, please call 1-800-345-8139 at Medtronic Diabetes 24- hours a day. Therefore, they recalled an estimated 3 million of the infusion sets with reference numbers MMT-396, MMT-397, MMT-398 and MMT-399 with lot numbers starting That Medtronic can communicate with you regarding our diabetes products by telephone, fax, mail and/or e-mail. But 2013’s recalls included one on the most serious level concerning the Medtronic MiniMed Paradigm insulin infusion set, with the FDA noting that “under certain conditions, the infusion set Medtronic MiniMed Sure-T infusion sets are used in conjunction with a pump to deliver a continuous dose of insulin to help people with diabetes maintain normal blood glucose levels. ALERT: Due to the inclement weather across much of the country, Medtronic deliveries are currently experiencing delays and there will be longer than normal hold times on the phone. Medtronic suggests that the sensor be worn on the abdomen only. ” The recall notice specifically identifies a vent in a piece that connects infusion sets to the pump’s reservoir as the source of the problem and indicates that infusion sets sold prior to April 2017 may have contained this component. Ideal for those insulin pump users who are lean or live an active lifestyle, the MiniMed™ Silhouette™ infusion set offers comfort and flexibility by allowing you to choose your insertion angle. If you’re having your infusion set coming loose, you may wish to try using a more Liver problems, such as cirrhosis or Gilberts Syndrome resulting in bilirubin levels greater than 54 mg/dL. Reporting problems. Beginning in February, Medtronic will be discontinuing the MiniMed™ Mio™ infusion set to make way for the newest version - the MiniMed™ Mio™ Advance infusion set! We understand that change isn’t always easy and are here to support you. Page 23: Accessories How to wear your pump There are different ways to wear your pump. Medtronic offers the widest range of infusion sets so that you can choose the right infusion set The Dangers of Medtronic Paradigm Quick-Set Infusion Sets for MiniMed Insulin Pump Medtronic Inc. Medtronic would like to remind customers that it is very important to carefully follow the Key Steps document included with the recall notification letter regarding the priming/fill-tubing Longer set wear may lead to poor blood glucose control and more hyperglycaemic episodes 3 Delaying your set change means you are 4 times more likely to have infusion site problems (itching, bruising, swelling and pain) 3 More set problems, such as poor adhesion and leakage, start to occur the longer the set is used 1 Look for the helpful days Infusion sets remain “the weakest link” in insulin pump treatment, with as many as 60% of pump users reporting infusion set failures for a variety of reasons. Medtronic MiniMed Insulin Pump Lawsuit. The MiniMed™ Mio™ Advance Infusion Set is designed with a pre-loaded inserter for quicker and easier set changes that require fewer steps. But 2013’s recalls included one on the most serious level concerning the Medtronic MiniMed Paradigm insulin infusion set, with the FDA noting that “under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin. The first infusion site was started yesterday at 3:30 pm. The FDA issues a Medtronic MiniMed Infusion Set Recall due to reports of hypoglycemia linked to problems with the vent membrane. and infusion sets have been the subject of a myriad of problems and defects over the years. The MiniMed Quick-Set. Beginning in February, Medtronic will be discontinuing the MiniMed™ Mio™ infusion set to make way for the newest version - the MiniMed™ Mio™ Advance infusion set! We understand that change isn’t always easy and are here to support you. Itching Bruising Swelling Pain More set problems, such as poor adhesion and leakage start to occur the longer the set is used1. Laura Cleverly. Diabetes. Automated insulin delivery is made possible through combining Medtronic insulin pump and continuous glucose monitoring technology. pissedconsumer. Medtronic has determined that if insulin, alcohol, or water is spilled on top of the insulin reservoir during the priming/fill-tubing process, the “vent membrane” can get wet and prevent the set from functioning properly. has recalled three million disposable infusion sets designed for their MiniMed Paradigm insulin pumps after discovering that some of them could deliver incorrect doses of insulin, potentially leading to injury or death. Medtronic MiniMed Silhouette Infusion Set offers Comfort and flexibility. I am on a Medtronic 640G and the MIO infusion set, 8mm cannula if memory serves me right, and had a spell of it stinging but changed to a longer cannula and the problem subsided, as with the rest of the suggestions the top/front thigh region works well for me and I no longer get a stinging sensation when Bolusing. 27. A Medtronic spokeswoman indicated that the company has received reports of hospitalizations that may be related to the problem, but the cases have not been confirmed. If the blockage occurs, the pump can give the patient too much insulin which can lead to hypoglycemia (low blood sugar) which can cause serous adverse physical problems and in some cases coma or death. I've been variously told that it might be stuck in customs Currently manufactured Medtronic MiniMed infusion sets that have been available since April 2017 include a design update of the defective component that Medtronic believes minimizes risks for insulin over-delivery following an infusion set change. Having said all this, my doctor, my nurse, the Medtronic "helper", none of these have any advice. By (b)(4) should not be used with the medtronic 508 insulin pump. In the span of 11 months (June 2013-May 2014), the manufacturer received 750 complaints about the infusion sets. The Minimed IV3000 transparent film is specifically designed to comfortably fit around all Medtronic branded infusion sets. For more information, please visit: http://www. The incidence of reported problems related to the P-Cap has been very rare (1-2 per million infusion sets). According to the Star Tribune , customers generally replace their infusion sets every two to three days, but they could have several months’ worth of supplies on hand. Click here to view our different infusion sets Struggling to control my diabetes on day 4. Here is a list of commonly used infusion sets and the equivalent Tandem brand names. The week of April 17, 2013, the FDA issued a Class II recall of the Medtronic MiniMed Paradigm Insulin Infusion Pump, intended for use to deliver insulin to people with diabetes. The Medtronic Minimed Quick-set® Infusion Set (MMT397) offers a 9mm soft cannula and 23 inch tubing for mostly everyone. Like the Revel 523 and 723 pumps, the 530G uses the same 180-unit and 300-unit reservoirs and infusion sets. Medtronic QuickSet Infusion Set utilizes a plastic cannula and a 90-degree insertion angle. 1,2. The most serious of these notices include recalls of Medtronic MiniMed Paradigm Insulin Infusion Sets and Infusion Set Reservoirs. Some people prefer to insert the infusion set by hand. 4X Poor Insulin Absorption Site irritation Why it is important to change your infusion set About Medtronic Together, we can change healthcare worldwide. Medtronic Insulin Pumps & Infusion Sets The Medtronic MiniMed Paradigm Insulin Pump is designed to deliver insulin to diabetes patients, making daily injections unnecessary. Its 30° angle makes it suitable for sporty individuals, lean adults and children. A design update in April 2017 corrected the problem but some patients still have lots of defective infusion sets. issued a Class I recall of their Quick-Set? Insulin Infusion sets, July 10, 2009. medtronic infusion set problems