BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4202959 · Received October 27, 2014

    Report

    Report Number
    3004753838-2014-31351
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 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. FUNCTIONAL TESTING WAS PERFORMED AND THE TRANSMITTER FAILED. THE ROOT CAUSE WAS DETERMINED TO BE A FAILED TRANSMITTER. A CAPA HAS BEEN INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682634 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9438-01

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR