BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5047883 · Received September 1, 2015

    Report

    Report Number
    3004753838-2015-80835
    Event Type
    Death
    Date Received
    September 1, 2015
    Date of Event
    July 11, 2015
    Report Date
    August 3, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED ALLEGED DEVICE MALFUNCTION. IT SHOULD BE NOTED THAT DIABETES IS A KNOWN CAUSE OF DEATH.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON 08/03/2015, TO STATE THE PATIENT PASSED AWAY ON (B)(6) 2015. REPORTEDLY, THE PATIENT WAS DIAGNOSED WITH DIABETES ON (B)(6) 2015 AND WAS HOSPITALIZED THE SAME DAY DUE TO A TRAUMATIC BRAIN INJURY AS A RESULT OF HER SUGARS BEING SO HIGH. PATIENT WAS HOSPITALIZED FOR REHABILITATION FOR 111 DAYS FROM (B)(6) 2015. PATIENT STARTED USING THEIR CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM ON (B)(6) 2015. AT THIS TIME, PATIENT WAS NON-VERBAL, NON-MOBILE AND HAD A FEEDING TUBE. PATIENT GOT A COLD THAT DEVELOPED INTO PNEUMONIA AND THEN PASSED AWAY. PATIENT WAS WEARING HER CGM AT THE TIME OF DEATH. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578335 DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22608-PNK 5201236

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death