BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 5733190 · Received June 17, 2016

    Report

    Report Number
    3004753838-2016-03488
    Event Type
    Death
    Date Received
    June 17, 2016
    Date of Event
    January 4, 2016
    Report Date
    May 20, 2016
    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). DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S WIFE CONTACTED DEXCOM ON 05/20/2016 TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2016. PATIENT'S WIFE STATED THAT ON (B)(6) 2016 AN EMPLOYEE FOUND THE PATIENT AND CALLED 911. THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND WAS UNRESPONSIVE. IT WAS LATER DETERMINED THAT THE PATIENT HAD A MASSIVE INTRACRANIAL HEMORRHAGE. THE PATIENT WAS IN THE HOSPITAL AND IN A COMA FROM (B)(6) 2016. THE PATIENT PASSED AWAY ON (B)(6) 2016. A DEATH CERTIFICATE WAS PROVIDED AND THE CAUSE OF DEATH WAS LISTED AS MASSIVE INTRACRANIAL HEMORRHAGE. DIABETES TYPE II AND HYPERTENSION WERE LISTED AS CONTRIBUTING CONDITIONS. THE PATIENT WAS NOT WEARING THE CONTINUOUS GLUCOSE MONITOR (CGM) AT THE TIME OF DEATH. THERE WAS NO ALLEGED DEVICE MALFUNCTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    TWO RECEIVERS (PART NUMBER STK-DR-001/SERIAL NUMBER (B)(4)/LOT NUMBER 520662 AND PART NUMBER STK-GL-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5191117) WAS RETURNED FOR EVALUATION. THE DEVICES WERE VISUALLY INSPECTED AND NO DEFECT WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURES DETECTED. A REVIEW OF THE DOWNLOADED RECEIVER LOGS DID NOT FIND ANY ERRORS. ADDITIONALLY, A TRANSMITTER (PART NUMBER STT-GL-003/SERIAL NUMBER (B)(4)/LOT NUMBER 5203733) WAS ALSO RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. THERE WERE NO ALLEGED MALFUNCTION REPORTED FOR THE RETURNED DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387789 NI MDS MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| O