BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6145277 · Received December 5, 2016

    Report

    Report Number
    3004753838-2016-52726
    Event Type
    Death
    Date Received
    December 5, 2016
    Date of Event
    May 22, 2016
    Report Date
    November 7, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DIABETES MELLITUS IS A KNOWN CONTRIBUTER TO MICROVASCULAR COMPLICATIONS.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016, THAT ON (B)(6) 2016, THE PATIENT PASSED AWAY DUE TO RENAL FAILURE. THE PATIENT'S WIFE REPORTED THAT ON (B)(6) 2016, THE PATIENT WAS RUSHED TO THE HOSPITAL DUE TO HEART FAILURE AND RENAL FAILURE. THE PATIENT HAD HEART SURGERY- TWO STENT PROCEDURES- AND WAS PLACED ON DIALYSIS. PATIENT WAS THEN SENT TO A HOSPICE AND PASSED AWAY ON (B)(6) 2016. PATIENT WAS NOT WEARING THE CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM AT THE TIME OF PASSING AS THEY HAD TAKEN IT OFF WHEN ADMITTED TO THE HOSPICE. THERE WAS NO ALLEGED DEVICE MALFUNCTION. REPORT OF DEATH WAS INITIATED TO CLOSE PATIENT'S ACCOUNT. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO PRODUCT OR DATA WAS RETURNED FOR INVESTIGATION. A CERTIFICATE OF DEATH WAS NOT PROVIDED. THE REPORTED DEATH COULD NOT BE CONFIRMED. A ROOT CAUSE WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795276 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| O COUMADIN| INSULIN| LASIX| STATIN