BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4211457 · Received October 29, 2014

    Report

    Report Number
    3004753838-2014-31445
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 3, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND NO DEFECTS. THE RECEIVER CASE WAS OPENED, FINDING THAT THE MOISTURE DETECTION STICKER HAD BEEN ACTIVATED. DUE TO MOISTURE DAMAGE THE RECEIVER WOULD NOT TURN ON; THEREFORE, USE TESTING COULD NOT BE PERFORMED, AND THE DATA LOG COULD NOT BE DOWNLOADED FOR REVIEW. AS MOISTURE DAMAGE IS A CONTRIBUTING FACTOR TO PERMANENT LOSS OF ANTENNA, THE CUSTOMER COMPLAINT HAS BEEN CONFIRMED. THE ROOT CAUSE FOR THE REPORTED EVENT IS MOISTURE DAMAGE.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT AN PERMANENT OUT OF RANGE SIGNAL ON (B)(6) 2014. AT THE TIME OF CONTACT, PATIENTS FATHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694036 PEDIATRIC G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22430

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR