BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3882338 · Received June 18, 2014

    Report

    Report Number
    3004753838-2014-08779
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT A HYPOGLYCEMIC EVENT AND CGM INACCURACIES COMPARED TO BLOOD GLUCOSE METER ON (B)(6) 2014. AT THE TIME OF THE HYPOGLYCEMIC EVENT, THE PATIENT'S DOMESTIC PARTNER CALLED PARAMEDICS. THE PARAMEDICS REPORTED THAT THE PATIENT'S CGM WAS POSSIBLY READING IN THE 110 MG/DL RANGE AND HIS BLOOD GLUCOSE METER WAS READING 30 MG/DL, AT WHICH TIME THE PARAMEDICS ADVISED FOR THE PATIENT TO TAKE A GLUCOSE SUPPLEMENT TO TREAT HIS LOW. THERE WAS NO FURTHER MEDICAL INTERVENTION. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, THE PATIENT DID NOT REPORT ANY MEDICAL INTERVENTION OR INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358276 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other