BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4388711 · Received January 6, 2015

    Report

    Report Number
    3004753838-2015-00049
    Event Type
    Malfunction
    Date Received
    January 6, 2015
    Date of Event
    December 9, 2014
    Report Date
    December 9, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT RECEIVER DEVICE WAS NOT RETURNED TO DEXCOM. THE TRANSMITTER DEVICE(9438-01/64EKE), USED WITH THE COMPLAINT RECEIVER DEVICE, WAS RETURNED ON 02/09/2015. THE RETURNED COMPLAINT TRANSMITTER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE TEST FAILED, CONFIRMING THE REPORTED EVENT OF A PERMANENT OUT OF RANGE SIGNAL. 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 A PERMANENT OUT OF RANGE SIGNAL ON (B)(6) 2014. PATIENT WAS ADVISED TO RESET THE DEVICE AND THE RESET WAS UNSUCCESSFUL FOR THE REPORTED ISSUE. AT THE TIME OF CONTACT WITH DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7805 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-BLU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR