BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITOR

    MDR report key: 11195286 · Received January 15, 2021

    Report

    Report Number
    MW5098873
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    January 13, 2021
    Report Date
    January 14, 2021
    Manufacturer
    DEXCOM INC
    Product Code
    QBJ
    UDI-DI
    00386270000255
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LEFT WITH NO CGM; WHILE INSERTING THE DEXCOM G6, THE APPLICATOR ON 3 UNITS FAILED TO RELEASE, LEAVING THE APPLICATOR STUCK TO MY BODY. ALTHOUGH I TRIED SEVERAL WAYS TO RELEASE THE STUCK CATCHES, I COULD NOT REMOVE THE APPLICATOR WITHOUT ALSO REMOVING THE SENSOR ITSELF. ALL 3 SENSORS HAD TO BE THROWN IN THE TRASH. DEXCOM LIMITS THE NUMBER OF UNITS YOU CAN GET AT ONCE TO 9. AS I AM AT THE END OF THAT CYCLE, I NOW HAVE NONE (BUT CAN'T ORDER MORE UNTIL FEBRUARY 22). WITHOUT THE SENSOR, MY INSULIN PUMP'S SOFTWARE (TANDEM TSLIM X2 WITH SMART IQ) IS RENDERED MOOT. CONTROL OF MY DIABETES IS JEOPARDIZED. THIS A KNOWN DEFECT WITH THE PRODUCT. I'VE HAD 3 OTHER UNITS DO THIS SINCE USING THE G6. INTERNET CHAT ROUTINELY MENTIONS THIS ISSUE, YET DEXCOM DOES NOT SEEM TO BE DOING ANYTHING TO ADDRESS IT, OTHER THAN SENDING OUT REPLACEMENT UNITS. MEANWHILE, MY CONTROL OF MY DIABETES WILL SUFFER AS A RESULT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78907 DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC G6 5278425 00386270000255
    78908 DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC G6
    78909 DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC G6
    78910 DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC G6
    78911 DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC G6
    78912 DEXCOM G6 CONTINUOUS GLUCOSE MONITOR INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED QBJ DEXCOM INC G6

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other