BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3892877 · Received June 24, 2014

    Report

    Report Number
    3004753838-2014-05705
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(4) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED SKIN IRRITATION AT SENSOR PATCH ADHESION SITE. PATIENT REPORTED CALLING HER DOCTOR ON (B)(6) 2014 TO DISCUSS NECESSARY ACTION IF RASH PERSISTS. PATIENT REPORTED USING A HYDRO-CORTISONE CREAM TO ALLEVIATE RASH. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY. AT THE TIME OF THE CALL WITH DEXCOM TECHNICAL SUPPORT, PATIENT REPORTED BEING GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368535 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other