MAUDE Adverse Event Report: MEDTRONIC MINIMED CGM SYSTEM; SENSOR, GLUCOSE, INVASIVE

Device Problem Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Date 10/10/2021

Event Type  malfunction  

Event Description

Minimed cgm glucose sensor for use with their 670g insulin pump have an absurdly high failure rate.My latest shipment has had a 50% failure rate.It is very common for the cgm sensor to show my blood sugar "below 40mg/dl" and a traditional finger stick will show my sugar is 120mg/dl.Other times there will be a difference of 100ml/dl between what the cgm system shows and what my sugar actually is, the system will show my sugar is in the normal range, approximately 120mg/dl and a traditional finger stick will read 250mg/dl.There are severe issues with the accuracy of the whole minimed 670g system and it should never have been approved by the fda to use in "auto mode".A quick (b)(6) search will bring up complaints going back to the introduction of the system saying the sensors are constantly reading 20-30mg/dl higher or lower than a standard finger stick reading.Their sensor are putting people in danger of either short term harm from hypoglycemia events of long term harm from repeated hyperglycemia events when the pump is reading much lower than their actual blood glucose readings.Another side effect - repeated unnecessary needle sticks from having to change sensors much more frequently than should be required.If the system could be remotely described as "reliable" or "good" then we would only need to change sensors 1 time per week, not 2-3 sensors per week.Fda safety report id # (b)(4).

• Brand Name: CGM SYSTEM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 12633715
• MDR Text Key: 277175759
• Report Number: MW5104614
• Device Sequence Number: 2
• Product Code: MDS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/10/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Weight: 104