BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4190989 · Received October 21, 2014

    Report

    Report Number
    3004753838-2014-31291
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 24, 2014
    Report Date
    September 25, 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. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. 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. HOWEVER, BASED ON THE DATA LOG, THE COMPLAINT OF LOSS OF ANTENNA WAS CONFIRMED. A CAPA HAS BEEN INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670097 G4 PLATINUM PEDIATRIC CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT22430

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR