BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G5

    MDR report key: 7384664 · Received March 29, 2018

    Report

    Report Number
    MW5076222
    Event Type
    Injury
    Date Received
    March 29, 2018
    Date of Event
    March 27, 2018
    Report Date
    March 28, 2018
    Manufacturer
    DEXCOM
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I AM ON THE DEXCOM G5, LOT NUMBER 5231430, I HAVE USED IT FOR ALMOST 3 MONTHS. THERE HAVE BEEN SEVERAL TIMES THAT I HAVE HAD A HIGH GLUCOSE AND THE DEXCOM G5 DID NOT ALERT ME OR IT WAS DELAYED. I HAVE HAD SEVERAL LOWS AND IT DID NOT ALERT ME. ON (B)(6) 2018 I WAS AT WORK CLIMBING UP AND DOWN A LADDER AND MY SUGAR HAD DROPPED TO 32. THE DEXCOM DID NOT ALERT ME AT ALL, I CAN'T TELL WHEN MY SUGAR DROPS OR GOES HIGH. I HAVE TESTED THE ALERTS EVERY NIGHT WHEN I PLUG THE DEVICE IN TO CHARGE. VIBRATION AND SOUND WORK PERFECTLY. I HAVE ALSO NOTICED THAT THE SENSOR HAS TROUBLE STAYING CONNECTED VIA BLUETOOTH TO THE DEVICE. I'M NOT SURE AS WHAT TO DO. THIS COULD HAVE BEEN A SERIOUS CASE OF HOSPITALIZATION DUE TO THE FAILURE OF THE DEVICE. I HAVE TALKED TO ONE GENTLEMAN AT (B)(6) THEY TOLD ME THAT IF THE DEVICE HAS SOUND AND VIBRATION THEN IT'S WORKING PROPERLY. I AM A MOTHER OF THREE WORKING TO SUPPORT MY FAMILY. ONE INCOME AS MY YOUNGEST DAUGHTER HAS MEDICAL ISSUES THAT PREVENT HER FROM GOING TO DAY CARE. SO IF I HAD GOTTEN HURT BY FALLING OR PASSING OUT DUE TO MY SUGAR DROPPING OR GOING TOO HIGH MY FAMILY WOULD BE OUT ON THE STREETS. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223317 DEXCOM G5 DEXCON G5 MDS DEXCOM DEXCOM G5 DX74103048

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Life Threatening| O