BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4816885 · Received June 3, 2015

    Report

    Report Number
    3004753838-2015-50139
    Event Type
    Death
    Date Received
    June 3, 2015
    Date of Event
    April 7, 2015
    Report Date
    May 6, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGED DEVICE MALFUNCTION. NEITHER THE DEVICE NOR DATA WAS PROVIDED FOR EVALUATION. THE OFFICIAL CAUSE OF DEATH WAS REPORTED TO BE A HEART ATTACK. ADDITIONALLY, IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RECEIVER WAS RETURNED FOR DEVICE EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND THERE WERE NO DEFECTS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST RESULTED IN NO FAILURES. A REVIEW OF THE DOWNLOADED DATA LOG DID NOT FIND ANY ERRORS. ADDITIONALLY, THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5191257) WAS RETURNED FOR DEVICE EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST RESULTED IN NO FAILURES.

    Description of Event or Problem · 1

    PATIENT'S WIFE CONTACTED DEXCOM CUSTOMER OPERATIONS ON (B)(6) 2015 TO REPORT THE PATIENT'S DEATH THAT OCCURRED ON (B)(6) 2015. PATIENT'S WIFE STATED THAT ON (B)(6) 2015 THE PATIENT WENT TO THE HOSPITAL AS HE WAS NOT FEELING WELL AND WAS ADMITTED TO THE EMERGENCY ROOM. THE PATIENT PASSED AWAY LATER THAT DAY FROM A HEART ATTACK. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357505 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5134297

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death