BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE MONITORING SYSTEM

    MDR report key: 6069501 · Received October 28, 2016

    Report

    Report Number
    MW5065736
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 28, 2016
    Manufacturer
    DEXCOM
    Product Code
    MDS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY DEXCOM G5 APP ON MY (B)(6) FAILED TO ALERT ME TO A FALLING BLOOD SUGAR SET AT 90 MG/KG AND THEN AT 55 MG/KG. THIS WHILE I WAS EXPERIENCING LOW BLOOD SUGAR SYMPTOMS AND WHICH I WAS TRYING TO TREAT. I WAS WITHOUT MY TRANSMITTER FOR THE G5 AS THE BATTERY HAD FAILED ON THE (B)(6). IT TOO (TRANSMITTER) WAS NOT REPORTING ALARMS EITHER. MY HYPOGLYCEMIA RESULTED IN SEIZURE AND BLACK OUT. MY (B)(6) ALARM WENT OFF AT 40 MG/KG. THIS IS THE FIRST TIME IN 45 PLUS YEARS OF A VERY ACTIVE LIFE WITH TYPE 1 DIABETES. I'VE NEVER HAD A SEIZURE OR BLACKED OUT. I'M NEW TO THIS PRODUCT AND WAS NOT MADE AWARE OF THE CURRENT ISSUES WITH THE TRANSMITTER OR (B)(6) APPLICATION AS IT PERTAINED TO ALARMS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714446 GLUCOSE MONITORING SYSTEM GLUCOSE MONITORING SYSTEM MDS DEXCOM G5 SM69700371

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L OTC MEDS: NONE. | RX MEDS: OMNIPOD