BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 2990593 · Received March 5, 2013

    Report

    Report Number
    3004753838-2013-00054
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT THAT ON (B)(6) 2013 AROUND 11:30 AM, HE HAD EXPERIENCED A HYPOGLYCEMIC EVENT AND LOST CONSCIOUSNESS. PATIENT'S WIFE CAME HOME, FOUND HIM UNRESPONSIVE AND CALLED PARAMEDICS. PARAMEDICS CAME AND ADMINISTERED GLUCAGON AND ORANGE JUICE. DEXCOM IS SEEKING FOR PATIENT TO RETURN HIS CGM IN ORDER FOR DEXCOM TO INVESTIGATE THE DATA AROUND THE TIME OF THE EVENT. AT THE TIME OF HIS CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT WAS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93849 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9500-27 5046614

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other