• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC GUARDIAN APP SENSOR, GLUCOSE, INVASIVE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC MINIMED MEDTRONIC GUARDIAN APP SENSOR, GLUCOSE, INVASIVE Back to Search Results
Device Problem Application Program Version or Upgrade Problem (2881)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2019
Event Type  malfunction  
Event Description
I have the medtronic guardian app, it continuously monitors my blood sugar. I have a prescription for the equipment so i figured it will fall under fda regulations. My (b)(6) updated to 13. 3 and the app stopped working. I have spoken twice with medtronic about it in case the first person was wrong but, they both said that the app will not run with the (b)(6) 13. 3 it needs to be downgraded to 13. 1. After it updates you can't downgrade it. I have called and spoken with an (b)(6) about it. Medtronics stance on it is that they are going to update their app but have no idea when it will be done which means until they bother to fix it their product is unusable. I spoke with the (b)(6) too and they said even if i bought another phone that it would force an update and the app will not work. Also, they can't factory reset to fix the problem because the operating system has already been updated. I'm complaining about the fact they knew this problem was coming and have no timeline to fix it. I figured there has to be some regulations for medtronic having to update their apps if they are deemed a medical necessity. The attitude i got from the medtronic's rep was (b)(6) keeps updating and we will fix it when we can. Which makes me think this will be an ongoing issue not a one time done issue. They should have least sent out warning (b)(6) is going to update don't accept it. There was no warning and now i'm caught in a lurch. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMEDTRONIC GUARDIAN APP
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key9540069
MDR Text Key173668277
Report NumberMW5091992
Device Sequence Number1
Product Code MDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2019
Is this a Product Problem Report? Yes
Device Operator
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

-
-