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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC QUICK-SET PARADIGM 6MM MMT-387 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR

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MEDTRONIC MINIMED MEDTRONIC QUICK-SET PARADIGM 6MM MMT-387 INFUSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MMT-387
Device Problem Material Deformation (2976)
Patient Problem Hyperglycemia (1905)
Event Date 07/05/2021
Event Type  malfunction  
Event Description
High glucose levels; medtronic insulin pump 770 and others. The canula on the medtronic quick set paradigm mmt-387 6mm continues to fold over and restrict insulin delivery. It has happened 3x to me resulting in high glucose levels. In speaking with my endocrinologist he said he is seeing the same thing and has had patients hospitalized with dka. The online diabetes forums are full of many folks saying the same thing with many of themselves or their children being hospitalized. I've been using medtronic insulin pumps and infusion sets for almost 30 years and i have not seen this before. Its a pretty recent thing and is causing chaos for people trying to manage their insulin dependent diabetes. I know that there is one manufacturer that makes everyone's infusion sets so i am guessing the problem is there. I've reported it to my medtronic rep multiple times. This is a big deal, it has happened 3 x plus. I can send photos of a removed site if you want to see what the canula looks like during a malfunction. It basically folds over and gets stuck under the tape on the side of the site so insulin does not go into the body or if it does it leaks over into the infusion hole at a reduced rate. It's a pretty common occurrence now and is a big concern. I haven't heard anything on a corporate level from medtronic but something needs to happen very soon. Thanks. Feel free to reach out if you want photos. I'm concerned someone is going to have life threatening problems resulting from this problem. Thanks (b)(6). Fda safety report id # (b)(4).
 
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Brand NameMEDTRONIC QUICK-SET PARADIGM 6MM MMT-387 INFUSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key12149610
MDR Text Key261229908
Report NumberMW5102445
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 07/08/2021
3 Devices were Involved in the Event: 1   2   3  
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMMT-387
Device Lot Number5294604
Was Device Available for Evaluation? Yes
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: 07/09/2021 Patient Sequence Number: 1
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