BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4171238 · Received October 14, 2014

    Report

    Report Number
    3004753838-2014-29420
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 3, 2014
    Report Date
    August 5, 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 RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND FOUND NO OBSERVATIONS RELATED TO THE COMPLAINT. A REVIEW OF THE RECEIVER DATA LOG CONFIRMED A HARDWARE ERROR CODE. THIS COMPLAINT WAS DEEMED REPORTABLE UPON COMPLETION OF DEVICE EVALUATION ON 09/18/2014. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE COMPONENT FAILURE.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO REPORT THAT ON (B)(6) 2014 PATIENT'S RECEIVER WOULD NOT TURN ON. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651123 G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22430-BLU

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR