BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5460564 · Received February 25, 2016

    Report

    Report Number
    3004753838-2016-01280
    Event Type
    Death
    Date Received
    February 25, 2016
    Date of Event
    January 21, 2016
    Report Date
    February 1, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000064
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S HUSBAND CONTACTED DEXCOM ON (B)(6) 2016, TO REPORT A PATIENT DEATH THAT OCCURRED ON (B)(6) 2016. PATIENT'S CAREGIVER CALLED EMERGENCY MEDICAL TECHNICIAN'S (EMT). PATIENT'S CAREGIVER PROVIDED CARDIOPULMONARY RESUSCITATION (CPR) UNTIL PARAMEDICS ARRIVED. PATIENT WAS NOT TAKEN TO THE HOSPITAL AS SHE WAS PRONOUNCED DEAD AT THE SCENE. PATIENT'S HUSBAND DID NOT STATE WHAT LEAD TO EMT'S BEING CALLED. PATIENT WAS WEARING DEXCOM CONTINUOUS GLUCOSE MONITOR (CGM) AT THE TIME OF DEATH. CAUSE OF DEATH WAS REPORTED TO BE AORTIC STENOSIS, SUDDEN CARDIAC DEATH, HYPERTENSION, AND DIABETES MELLITUS. PATIENT WAS TAKING MANY MEDICATIONS. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD MODERATELY ADVANCED PARKINSON'S DISEASE. PATIENT WAS TAKEN DIRECTLY TO THE FUNERAL HOME. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. THERE WAS NO ALLEGED DEVICE MALFUNCTION. IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH DUE TO COMPLICATIONS OF THE DISEASE. A DEATH CERTIFICATE WAS PROVIDED, CONFIRMING CAUSE OF DEATH. IMMEDIATE CAUSE OF DEATH WAS DETERMINED AS BEING 1.) CRITICAL AORTIC STENOSIS 2.) HYPERTENSION 3.) DIABETES MELLITUS. ADDITIONALLY THE PATIENT'S DEATH CERTIFICATE CONFIRMS THAT THE PATIENT HAD PARKINSON'S DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118497 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5190868 00386270000064

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death| O LEVADOPA