BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATNIUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4924069 · Received July 19, 2015

    Report

    Report Number
    3004753838-2015-50261
    Event Type
    Death
    Date Received
    July 19, 2015
    Date of Event
    February 2, 2015
    Report Date
    June 23, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO MALFUNCTION ALLEGED AGAINST THE DEVICE AND THE DEVICE WAS NOT BEING USED AT THE TIME OF EVENT. IT SHOULD BE NOTED THAT DIABETES IS A KNOWN CAUSE OF DEATH.

    Description of Event or Problem · 1

    PATIENT'S CONTACTED DEXCOM ON 06/23/2015, TO REPORT THAT ON (B)(6) 2015, THE PATIENT PASSED WAY. REPORTEDLY, THE PATIENT HAD THE FLU AND KETOACIDOSIS, AND WAS NOT WEARING THEIR DEXCOM CONTINUOUS GLUCOSE MONITORING SYSTEM AT THE TIME FOR UNKNOWN REASONS. THE PATIENT'S ROOMMATES FOUND HIM, CALLED THE PARAMEDICS AND ATTEMPTED CARDIAC PULMONARY RESUSCITATION (CPR) ON THE PATIENT WHILE WAITING. THE PARAMEDICS ARRIVED AND CONTINUED CPR AND GOT THE PATIENT PULSE BACK BRIEFLY, BUT WERE UNSUCCESSFUL AND THE PATIENT EXPIRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467926 G4 PLATNIUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5195774

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death THYROID MEDICINE