BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3981910 · Received August 5, 2014

    Report

    Report Number
    3004753838-2014-25186
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    September 28, 2013
    Report Date
    July 23, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS PROVIDED FOR INVESTIGATION. HOWEVER, INVESTIGATION WAS LIMITED DUE TO DEVICE CONDITION. RECEIVER LOG WAS DOWNLOADED AND AN EVALUATION FOUND NO ERRORS RELATED TO COMPLAINT. CUSTOMER COMPLAINT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO CLAIM NO AUDIO OUTPUT ON (B)(6) 2013. 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
    457799 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR