MINIMED CONNECT MMT-7018NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-23 for MINIMED CONNECT MMT-7018NA manufactured by Medtronic.

Event Text Entries

[53336646] The minimed connect uploader is a medtronic device that is used to transfer relevant interstitial glucose and insulin info from a glucose sensor equipped insulin pump to the user's (b)(6) via (b)(6) and a proprietary app developed by medtronic. When all parts are working, caregivers can access that info instantly via the user's carelink website, and receive text notifications of alarms for significant events (high and low sugars, threshold suspends being the most important). For the past several months, the app often quit working, even though it is never closed by the user. When this happens, test alarms are not generated. Recently, the app closed 7 times in less than 3 days. This leads to potential hypoglycemic events unk to the caregiver, whereas the device was developed and purchased to prevent this very thing from occurring. Medtronic has been aware of this problem with the app since the first month of it going on the market (september 2015), but as of this writing they have not made any changes to the app or tried to fix the problem, yet they continue to sell the device as if it works 24/7.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5064352
• MDR Report Key: 5905948
• Date Received: 2016-08-23
• Date of Report: 2016-08-23
• Date of Event: 2016-08-20
• Date Added to Maude: 2016-08-26
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: MINIMED CONNECT
• Generic Name: MINIMED CONNECT
• Product Code: PJT
• Date Received: 2016-08-23
• Model Number: MMT-7018NA
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MEDTRONIC

Patients

Patient Number	Treatment	Outcome	Date
1	0		2016-08-23