BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5112034 · Received September 29, 2015

    Report

    Report Number
    3004753838-2015-81379
    Event Type
    Death
    Date Received
    September 29, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 4, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGED DEVICE MALFUNCTION. IT WAS STATED THAT PATIENT EXPIRED ON OR AFTER (B)(6) 2015. THE CAUSE OF DEATH IS UNKNOWN. IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH. HOWEVER, A CONCLUSIVE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONFIRMED WITHOUT THE CERTIFICATE OF DEATH.

    Description of Event or Problem · 1

    PATIENT'S DAUGHTER CONTACTED DEXCOM TECHNICAL SUPPORT ON 09/04/2015, TO REPORT A PATIENT DEATH THAT OCCURRED ON OR AFTER (B)(6) 2015. EXACT DATE OF DEATH IS NOT AVAILABLE. PATIENT'S DAUGHTER STATED THAT SHE CANNOT CONFIRM IF PATIENT WAS WEARING DEXCOM SENSOR AT THE TIME OF DEATH OR USING DEXCOM SYSTEM. PATIENT'S DAUGHTER REPORTED THAT PATIENT PASSED AWAY IN THE SWIMMING POOL. AT THE TIME OF CONTACT, THE CORONER HAD NOT YET DETERMINED CAUSE OF DEATH. IT WAS FURTHER MENTIONED THAT THE PATIENT HAD CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY, DATE UNSPECIFIED, AND HAD BEEN RECENTLY DIAGNOSED WITH GASTROPARESIS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641053 DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-PNK 5202000

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death