BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 6993928 · Received November 1, 2017

    Report

    Report Number
    3004753838-2017-97559
    Event Type
    Death
    Date Received
    November 1, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 4, 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 (B)(6) 2017, THE PATIENT'S BROTHER REPORTED THAT THE PATIENT PASSED AWAY. IT IS UNKNOWN IF THE PATIENT WAS USING THE DEXCOM SYSTEM AT THE TIME. THE PATIENT'S BROTHER DID NOT PROVIDE ADDITIONAL INFORMATION. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772790 NI CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death