BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6574105 · Received May 17, 2017

    Report

    Report Number
    3004753838-2017-40449
    Event Type
    Death
    Date Received
    May 17, 2017
    Date of Event
    April 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CAUSE OF CARDIOVASCULAR COMPLICATIONS AND DEATH.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 05/26/2016 THAT ON (B)(6) 2016, THE PATIENT PASSED AWAY. PATIENT'S WIFE REPORTED THAT THE PATIENT WAS UNRESPONSIVE AT HOME AND CALLED EMERGENCY MEDICAL TECHNICIANS (EMTS). EMTS ARRIVED AND TRANSPORTED PATIENT TO HOSPITAL WHERE HE WAS PRONOUNCE DEAD ON ARRIVAL. PATIENT WAS WEARING WAS THE CONTINUOUS GLUCOSE MONITOR (CGM) AT THE TIME OF DEATH. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THERE WAS NO ALLEGED DEVICE MALFUNCTION. NO PRODUCT OR DATA WAS RETURNED FOR EVALUATION. A CERTIFICATE OF DEATH WAS PROVIDED. DEATH CERTIFICATE INDICATED THAT THE IMMEDIATE CAUSE OF DEATH WAS DETERMINED TO BE ATHEROSCLEROTIC AND HYPERTENSIVE CARDIO DISEASE. DIABETES MELLITUS WAS ANOTHER CONDITION WHICH CONTRIBUTED TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354846 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| O