BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3230293 · Received July 16, 2013

    Report

    Report Number
    3004753838-2013-00186
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 17, 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 SHE HAD SUFFERED A HYPOGLYCEMIC EPISODE AND LOST CONSCIOUSNESS. PATIENT LAID DOWN FOR A NAP AROUND 3 PM AND NEVER AWOKE. PATIENT'S (B)(6) SON FOUND HER UNRESPONSIVE AROUND 6 PM AND CALLED PARAMEDICS. PATIENT WAS TREATED ON THE SCENE WITH IV AND A DEXTROSE INJECTION. SHE WAS ALSO GIVEN SOME FOOD AFTER SHE REGAINED CONSCIOUSNESS. DEXCOM SOUGHT TO OBTAIN CGM¿S DATA FROM PATIENT IN ORDER TO INVESTIGATE CGM READINGS AROUND THE TIME OF THE EVENT. AT THE TIME OF HER CALL TO DEXCOM TECHNICAL SUPPORT, PATIENT WAS FEELING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329903 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other