BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4251472 · Received November 14, 2014

    Report

    Report Number
    3004753838-2014-31777
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 17, 2014
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE TRANSMITTER THAT WAS USED WITH THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION ON 11/11/2014. 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 DEFECTIVE TRANSMITTER. A CAPA HAS BEEN INITIATED FOR THIS ISSUE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736593 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR