BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4251835 · Received November 14, 2014

    Report

    Report Number
    3004753838-2014-25857
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. HOWEVER, THE DEVICE DOES NOT TURN ON. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT CONFIRM THE REPORTED EVENT OF AN INTERMITTENT AUDIO OUTPUT.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM INTERMITTENT AUDIO OUTPUT PATIENT EXPERIENCED ON (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, DURING THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S FATHER TO TEST THE ALERT FUNCTIONALITY AND REPORTED ALERTS WERE FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738410 G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22430-PNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR