BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4646050 · Received March 31, 2015

    Report

    Report Number
    3004753838-2015-50033
    Event Type
    Death
    Date Received
    March 31, 2015
    Date of Event
    November 3, 2014
    Report Date
    November 4, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RECEIVER AND TRANSMITTER THAT THE PATIENT WAS USING WERE RETURNED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RECEIVER BEING USED AT THE TIME OF DEATH WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THERE WAS NO FAILURE DETECTED. A REVIEW OF THE RECEIVER LOG DID NOT FIND ANY ERRORS. IN ADDITION, TWO TRANSMITTERS ((B)(4) LOT NUMBER 5049553, AND (B)(4) LOT NUMBER 5110239) BEING USED WITH THE RECEIVER WERE ALSO RETURNED FOR EVALUATION. THE DEVICES WERE VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED AND BOTH TRANSMITTERS FAILED. IT SHOULD BE NOTED THAT BOTH TRANSMITTERS WERE BEING USED PAST THE RECOMMENDED SIX MONTH BATTERY LIFE PERIOD; THEREFORE, THE DEVICES WERE PERFORMING AS EXPECTED. THERE WAS NO REPORTED MALFUNCTION. THE DEATH CERTIFICATE WAS RECEIVED. CAUSES OF DEATH WERE CARDIOPULMONARY ARREST, COMA, AND BRAINSTEM STROKE.

    Description of Event or Problem · 1

    ON (B)(6) 2015, PATIENT'S DAUGHTER REPORTED ADDITIONAL INFORMATION THAT WHEN SHE FOUND HER MOTHER, THE RECEIVER DISPLAY SCREEN HAD CHANGE SENSOR. THE PATIENT WAS ALSO WEARING A CONTINUOUS POSITIVE AIRWAY PRESSURE MACHINE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT'S PHYSICIAN CONTACTED DEXCOM ON (B)(6) 2015, TO REPORT THAT THE PATIENT PASSED AWAY ON (B)(6) 2014. THE PATIENT'S DAUGHTER HAD FOUND HER AT HOME, UNRESPONSIVE, BUT STILL ALIVE. PATIENT PASSED AWAY WHILE IN THE HOSPITAL. THE CAUSE OF DEATH WAS ATTRIBUTED TO A POSSIBLE BRAIN STEM STROKE, PER THE PATIENT'S DAUGHTER. THE PRODUCT WARRANTY HAD EXPIRED ON (B)(6) 2013, AND THE PATIENT WAS MADE AWARE OF THIS AND ADVISED TO ORDER A NEW RECEIVER ON (B)(6) 2014. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210303 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-PNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death