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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SURE-T INFUSION SETS

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MEDTRONIC SURE-T INFUSION SETS Back to Search Results
Device Problems Bent (1059); Material Opacification (1426); Material Too Rigid or Stiff (1544); Device Markings/Labelling Problem (2911)
Patient Problem No Information (3190)
Event Date 10/25/2017
Event Type  Injury  
Event Description
On (b)(6) 2017, i first noticed that the box of sure-t infusion sets that i had opened for use with my medtronic paradigm insulin pump had several issues, most disturbing was that the needle which stays in me for 3 days and is supposed to be perpendicular to the base of the set was bent. Also the lines that marked the units of insulin on the reservoirs i used with the pump were all at an odd angle. Over the next few weeks, medtronic sent me multiple replacement infusion sets and reservoirs from multiple lot numbers. They all had the same and new issues. Some sets had rough, opaque tubing which made it impossible to see if there were any air bubbles in the line. There were raised ridges of plastic on the sides of the barrels of the reservoirs. I often couldn't get the infusion sets and reservoirs to lock together and when they did lock together they would be at an angle, which made it very difficult to get the reservoir to lock into the pump. I also regularly had issues with insulin spilling out of the vial while i was trying to fill the reservoir when i was changing a set. Considering medtronic's voluntary infusion set recall - which could cause an overdelivery of insulin if the top of the reservoir got wet - this was very concerning, especially when i experienced a hypoglycemic event for the first time in weeks on (b)(6) 2017 shortly after changing a set. I reported this and all of the increasingly concerning number of issues to medtronic and sent them photos of the supply issues which they agreed were concerning. Initially they were appropriate and promised that they would look into the issues. I also showed the supply issues to my diabetes nurse educator and diabetes dr at the (b)(4). They had never seen anything like the defects that were apparent and were very concerned about how medtronic was handling the situation. I left some of the defective at the jostin while i waited for medtronic to make good on their promises. It took them over a week to mail me a ups return label so that i could return the 10+ boxes of defective supplies to them in a box that i had to supply. It took even longer for me to receive the canisters and return-mailing envelopes for any supplies that had been opened and needed to be sent via usps. Three weeks into this nightmare, i got sick for the first time in several years - i had a fever of 102 degrees for close to a week. My drs and medtronic agreed that i was most likely the stress of a defective pump and supplies that had weakened my immune system enough for me to get so sick. I was unable to return the supplies to medtronic once i finally received their return label in the mail. They called me around (b)(6) 2017 to ask why i hadn't returned the supplies, could hear how sick i was and told me not to worry about returning the defective supplies until i was better, in the meantime my dr escalated things by contacting the local medtronic rep to help get the situation rectified. I finally took several boxes to the ups store and usps on (b)(6) 2017 to return all of the defective supplies to medtronic. On (b)(6) 2017 received a call from (b)(6), one of the many people at medtronic who promised to help and then disappeared. She asked where the supplies were. I told her that i had returned them the day before and asked why she hadn't contacted me despite promising to do so, where my replacement supplies were and why she couldn't look in her own system to see that what i had returned to medtronic was en route to them. She told me she hadn't been in touch because i had escalated things and she could see that other people at medtronic were working up on the situation, that it would not too difficult for her to look at the shipping info for the boxes i had sent her, and that a hold had been put on my account so that no more supplies could be sent to me until they receive the defective supplies. I'd returned and that their shipping dept was slow so it would take a few days for them to be entered into their system. Once the hold was lifted on my account, it would then be up to me to call the 24/7 medtronic help line to request more supplies "if i still wanted them. " i was very frustrated by then. My insulin pump is not a toy - it is a medical device that i rely on to keep me alive. For 5 weeks medtronic was unable to provide me with viable supplies but somehow it was now up to me to guess when the hold had been lifted from my account, a hold which had been added without anyone telling me about it, and then to call them for more supplies that i could only assume would be defective given the number of lot numbers that they had already sent me. At one point during this nightmare, a medtronic senior supv, (b)(6), tried to convince me that it was normal for my insulin pump to lose time on a regular basis and for the reservoir area of the pump to reek of insulin. He insisted that insulin has a strong smell and therefore unless i saw moisture in the reservoir area the insulin odor was no cause for concern. Since i had received a replacement pump in (b)(6) 2017 when my pump kept losing time and the reservoir area reeked of insulin i disagreed with him, as did he the local rep, her supv and my dr. Tony sent me a replacement pump because there was an issue with the motor arm cap on the one i had and the reservoir area of the new pump smelled normal until 3 days later when i changed my set and it already reeked of insulin. Insulin evaporates quickly, which is part of the reason there is an odor to it, so that it will be obvious if it has leaked into the pump, but evaporated. The local rep offered to send me another replacement pump, but ultimately agreed with me that until the supply issue was addressed. I would continue to have the same issues so there was no point in replacing the pump until they could fix the supply issues. I haven't heard from anyone from medtronic since (b)(6) 2017. For all they know i could be dead. I was able to switch tandem t-slim x2 insulin pump and i also sue a dexcom g5 cgm system, but my medtronic pump is still under warranty and medtronic has yet to provide me with any viable replacement supplies for which i and my insurance company have paid. Medtronic continued to agree that there was a problem with their supplies and that they wanted to fix it and i took them at their word. Ultimately they seemed more interested in getting all of the defective supplies returned so that they could make the problem disappear. They even took the supplies that i had left with my dr and told everyone that i wanted back. I do still have some of their defective supplies as well as my medtronic insulin pump. I also have 100+ photos of the defective supplies that i returned to them, as well as copious notes from the multiple phone calls i had with various people at medtronic. I'm still horrified at how i was treated and how little concern they showed for my health. This was incredibly stressful and traumatic, which is why it has taken me this long to file my complaint, but i don't want anyone else to be harmed by medtronic's products.
 
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Brand NameSURE-T INFUSION SETS
Type of DeviceSURE-T INFUSION SETS
Manufacturer (Section D)
MEDTRONIC
MDR Report Key7202986
MDR Text Key97803122
Report NumberMW5074639
Device Sequence Number3
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/16/2018
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received01/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/17/2018 Patient Sequence Number: 1
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