BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4327181 · Received December 12, 2014

    Report

    Report Number
    3004753838-2014-29755
    Event Type
    Death
    Date Received
    December 12, 2014
    Date of Event
    November 13, 2014
    Report Date
    November 19, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED TO DEXCOM ON (B)(6) 2014 THAT A PATIENT HAD PASSED AWAY AND WAS WEARING A DEXCOM DEVICE AT THE TIME OF DEATH. THE DISTRIBUTOR REPORTED THAT THEY WERE UNABLE TO OBTAIN FURTHER INFORMATION FROM THE PATIENT'S HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807181 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Death ANIMAS VIBE INSULIN PUMP