BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6948441 · Received October 13, 2017

    Report

    Report Number
    3004753838-2017-94025
    Event Type
    Death
    Date Received
    October 13, 2017
    Date of Event
    August 13, 2017
    Report Date
    September 15, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 09/15/2017, THAT ON (B)(6) 2017, THE PATIENT WAS INVOLVED IN A CAR ACCIDENT. THE PATIENT'S MOTHER STATED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL AFTER THE CAR ACCIDENT AND PASSED AWAY ON (B)(6) 2017. A DEATH CERTIFICATE WAS PROVIDED AND IT WAS INDICATED THAT THE CAUSE OF DEATH WAS SEQUELAE OF BLUNT IMPACT TRAUMA. ADDITIONALLY, IT WAS IT WAS REPORTED THAT THE PATIENT WAS USING THE DEXCOM SYSTEM AT THE TIME OF THE ACCIDENT; HOWEVER, THERE WAS NO ALLEGATION MADE AGAINST THE DEXCOM CGM SYSTEM. DATA INVESTIGATION WAS CONDUCTED TO REVIEW EVENTS OCCURRED LEADING UP TO LAST USE OF DEVICE. THE DATA INVESTIGATION DISPLAYS LAST KNOWN ESTIMATED GLUCOSE VALUE WAS 227 MG/DL ON (B)(6) 2017 AT 10:50 AM.  IT SHOULD BE NOTED THAT PATIENT'S HIGH AND LOW ALERTS WERE NOT ENABLED UP TO THE TIME OF THE LAST KNOWN USE OF THE DEVICE. NO ROOT CAUSE TO BE DETERMINED AS THERE WAS NO ALLEGATION AGAINST THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728337 NI CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death