BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5062020 · Received September 8, 2015

    Report

    Report Number
    3004753838-2015-81015
    Event Type
    Death
    Date Received
    September 8, 2015
    Date of Event
    January 23, 2015
    Report Date
    February 4, 2015
    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). THERE WAS NO REPORTED DEVICE MALFUNCTION. DATA WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED. IT SHOULD BE NOTED THAT DIABETES IS A KNOWN CAUSE OF DEATH; HOWEVER, A DEFINITIVE ROOT CAUSE CANNOT BE DTERMINED.

    Description of Event or Problem · 1

    TERRITORY BUSINESS MANAGER CONTACTED DEXCOM TECHNICAL SUPPORT, TO REPORT THAT THE PATIENT HAD EXPIRED ON (B)(6) 2015. THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL ON (B)(6) 2015 FOR A RISE IN CREATINE. PATIENT WAS RELEASED TO A REHABILITATION NURSING FACILITY ON (B)(6) 2015. PATIENT EXPIRED IN THE NURSING FACILITY ON (B)(6) 2015. THE PATIENT WAS NOT WEARING THE CONTINUOUS GLUCOSE MONITORING SYSTEM AT THE TIME OF DEATH. THE PATIENT'S WIFE STATED THAT THE CAUSE OF DEATH WAS PERSISTENT EPSTEIN-BARR, CONGESTIVE HEART FAILURE, AND INSULIN DEPENDENT DIABETES. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592112 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5187478

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death