BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3790962 · Received May 5, 2014

    Report

    Report Number
    3004753838-2014-05548
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    August 20, 2013
    Report Date
    August 30, 2013
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 AND CLAIMED THAT ON (B)(6) 2013 PATIENT'S SENSOR ADHESION PATCH WAS FAILING. PATIENT'S MOTHER STATED THAT PATIENT USED TEGADERM TO ASSIST IN SENSOR PATCH ADHESION. PATIENT'S MOTHER STATED THAT PATIENT BEGAN TO EXPERIENCE ITCHING AT PATCH ADHESION SITE WHERE TEGADERM HAD BEEN USED. UPON ADHESION PATCH REMOVAL, PATIENT FOUND RASH AND REDNESS. PATIENT'S MOTHER STATED THAT SHE SUSPECTS RASH WILL CAUSE SCARRING. PATIENT'S MOTHER STATED THAT THE REACTION WAS CAUSED BY THE TEGADERM, AND NOT BY THE DEXCOM DEVICE. NO MEDICAL INTERVENTION WAS NECESSARY. AT THE TIME OF THE CALL, PATIENT'S MOTHER REPORTED THAT PATIENT WAS HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267579 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE: MDS MDS DEXCOM, INC. 9500-27 5073053

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other