BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4903903 · Received July 9, 2015

    Report

    Report Number
    3004753838-2015-50233
    Event Type
    Death
    Date Received
    July 9, 2015
    Date of Event
    May 31, 2015
    Report Date
    June 12, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO RECEIVERS WERE RETURNED FOR EVALUATION. IT IS UNKNOWN WHICH DEVICE WAS BEING USED AT THE TIME OF EVENT. THE RECEIVER (PART NUMBER STK-GL-BLU/SERIAL NUMBER (B)(4)/LOT NUMBER 5067284) WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS. THE RECEIVER (PART NUMBER STK-GL-BLU/SERIAL NUMBER (B)(4)/LOT NUMBER 5150449) WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ERRORS. THE TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5195181) BEING USED WITH THE DEVICES WAS ALSO RETURNED FOR EVALUATION. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THE PATIENT'S DEATH CERTIFICATE WAS RECEIVED ON 07/14/2015, HOWEVER, THE CAUSE OF DEATH IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGED DEVICE MALFUNCTION. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS AN INTRACRANIAL HEMORRHAGE. ADDITIONALLY, DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH.

    Description of Event or Problem · 1

    PATIENT'S LIFE PARTNER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT PATIENT'S DEATH THAT OCCURRED ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT WAS FOUND UNRESPONSIVE AT HOME, BY THEIR LIFE PARTNER, WHO ADMINISTERED GLUCAGON WHICH HAD NO EFFECT. THE PARAMEDICS WERE CALLED AND THE PATIENT WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT WAS DIAGNOSED WITH AND TREATED FOR AN INTRACRANIAL HEMORRHAGE. THE PATIENT DID NOT SURVIVE, HOWEVER, AND PASSED ON (B)(6) 2015. THE PATIENT WAS WEARING THE CGM DEVICE AT THE TIME OF THE EVENT BUT IT WAS REMOVED WHILE HE WAS AT THE HOSPITAL. THERE WAS NO ALLEGED DEVICE MALFUNCTION. THE CAUSE OF DEATH WAS AN INTRACRANIAL HEMORRHAGE. NO ADDITIONAL EVENT INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447449 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-BLU NI

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death| H