MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC 670 G AND GUARDIAN 6 CGM; SENSOR, GLUCOSE, INVASIVE

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

I have used the medtronic 670g insulin pump for approx 2 years.In that time i have had multiple failures with the cgm and multiple insulin pump failures as well.I do not know how the fda can allow the production and sale of a pump/cgm combination that has such a high rate of failure.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC 670 G AND GUARDIAN 6 CGM
• Type of Device: SENSOR, GLUCOSE, INVASIVE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 11900706
• MDR Text Key: 253691629
• Report Number: MW5101602
• 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: 05/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• 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 Age: 28 YR
• Patient Weight: 98