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

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).

• Brand Name: MEDTRONIC QUICK-SET PARADIGM 6MM MMT-387 INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 12149610
• MDR Text Key: 261229908
• Report Number: MW5102445
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• 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 Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/01/2022
• Device Model Number: MMT-387
• Device Lot Number: 5294604
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 100