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U.S. Department of Health and Human Services

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

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MEDTRONIC MINIMED GUARDIAN CGM SENSOR, GLUCOSE, INVASIVE Back to Search Results
Model Number
Device Problems Crack (1135); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems Hypoglycemia (1912); Seizures (2063)
Event Date 09/11/2020
Event Type  Injury  
Event Description
I just found out about this. I wear a medtronic 670g insulin pump and cgm. I've now had the pump replaced for the 4th time due to a crack on the back of the insulin pump leading to complete pump failure. The cgm fails prematurely and gives very inaccurate readings. This has caused me to have severe low blood sugar with seizures. The cgm says the glucose is 100 but the actual blood glucose is 40. There are many customers with this same problem. I think medtronic is covering up the reports. Fda safety report id# (b)(4).
 
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Brand NameGUARDIAN CGM
Type of DeviceSENSOR, GLUCOSE, INVASIVE
Manufacturer (Section D)
MEDTRONIC MINIMED
MDR Report Key10534902
MDR Text Key207159595
Report NumberMW5096605
Device Sequence Number5
Product Code MDS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 09/11/2020
5 Devices were Involved in the Event: 1   2   3   4   5  
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number
Was Device Available for Evaluation? No Answer Provided
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

Patient Treatment Data
Date Received: 09/14/2020 Patient Sequence Number: 1
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