BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6153324 · Received December 7, 2016

    Report

    Report Number
    3004753838-2016-52895
    Event Type
    Death
    Date Received
    December 7, 2016
    Date of Event
    October 30, 2016
    Report Date
    November 17, 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

    DEXCOM WAS MADE AWARE ON 11/17/2016 THAT ON (B)(6) 2016, THAT THE PATIENT PASSED AWAY. PATIENT'S WIFE REPORTED THAT THE PATIENT PASSED AWAY AT HOME DUE TO CARDIAC ARREST. EMERGENCY MEDICAL TECHNICIANS (EMTS) ARRIVED AND THE PATIENT'S BODY WAS TRANSPORTED TO A HOSPITAL. A COPY OF THE CERTIFICATE OF DEATH WAS NOT PROVIDED. THE PATIENT WAS NOT WEARING THE CONTINUOUS GLUCOSE MONITOR (CGM) AT THE TIME OF DEATH. THERE WAS NO ALLEGED DEVICE MALFUNCTION. ADDITIONAL EVENT OR PATIENT INFORMATION IS NOT AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A RECEIVER (PART NUMBER STK-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5220275) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND NO FAILURES WERE DETECTED. A REVIEW OF THE DATA LOG DID NOT FIND ANY ERRORS. ADDITIONALLY, A TRANSMITTER (PART NUMBER STT-GF-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5216445) WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. FUNCTIONAL TEXTING AND A PAIRING TEST WAS PERFORMED AND THE TESTS PASSED. THE DEVICES WERE DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THERE WAS NO ALLEGATIONS TO THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803266 NI CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| L