BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3895144 · Received June 25, 2014

    Report

    Report Number
    3004753838-2014-08954
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 30, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INTERNATIONAL DISTRIBUTOR CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT ON BEHALF OF PATIENT A HYPOGLYCEMIC EVENT AND CGM INACCURACIES ON (B)(6) 2014. PATIENT CLAIMS THAT SHORTLY AFTER CHECKING CGM VALUES THEY BECAME NAUSEOUS AND SELF-TREATED WITH A (B)(6). PATIENT REPORTED THEY THEN EXPERIENCED A HYPOGLYCEMIC EVENT ACCOMPANIED BY CRAMPS AND LOST CONSCIOUSNESS. PATIENT WAS ATTENDED TO BY AN EMERGENCY PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371296 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-25 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other