BEUDAMED
    FDA Adverse Event Death Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4654714 · Received April 2, 2015

    Report

    Report Number
    3004753838-2015-50051
    Event Type
    Death
    Date Received
    April 2, 2015
    Date of Event
    March 6, 2015
    Report Date
    March 6, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION. THE PATIENT'S WIFE CONFIRMED THAT THE PATIENT HAD NOT YET BEGUN USE OF THE CGM SYSTEM. HOWEVER, IT SHOULD BE NOTED THAT DIABETES MELLITUS IS A KNOWN CAUSE OF DEATH.

    Description of Event or Problem · 1

    PATIENT'S WIFE CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT THE PATIENT FELL INTO A COMA ON 03/06/2015. PATIENT'S WIFE CALLED DEXCOM BACK ON (B)(6) 2015 TO REPORT THAT THE PATIENT HAD PASSED AWAY. PATIENT'S WIFE CONFIRMED THAT THE PATIENT DEATH WAS NOT RELATED TO THE CONTINUOUS GLUCOSE MONITORING (CGM) DEVICE AND THAT THE PATIENT HAD NOT ACTUALLY BEGUN USE OF THE CGM SYSTEM; THE PACKAGE REMAINED UNOPENED. NO ADDITIONAL EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217577 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| H| O