BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3882079 · Received June 18, 2014

    Report

    Report Number
    3004753838-2014-05699
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 AND CLAIMED THAT ON (B)(6) 2014 PATIENT EXPERIENCED ALLERGIC REACTION AND RASH AT AND AROUND SENSOR PATCH ADHESION SITE. PATIENT SOUGHT MEDICAL INTERVENTION FROM PHYSICIAN AND WAS INFORMED OF NICKEL ALLERGY. PATIENT WAS ADVISED TO DISCONTINUE USE OF CGM. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT, PATIENT'S MOTHER REPORTED PATIENT WAS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358173 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other