BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4103379 · Received September 19, 2014

    Report

    Report Number
    3004753838-2014-29276
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    December 9, 2013
    Report Date
    December 9, 2013
    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). THE RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND FOUND NO OBSERVATIONS RELATED TO THE COMPLAINT. A REVIEW OF THE RECEIVER DATA LOG CONFIRMED A HARDWARE ERROR CODE. THIS COMPLAINT WAS DEEMED REPORTABLE UPON COMPLETION OF DEVICE EVALUATION ON (B)(4)2014. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE COMPONENT FAILURE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT HAVING TO PRESS THE CENTER BUTTON MULTIPLE TIMES ON THE RECEIVER TO GET THE SCREEN TO APPEAR ON (B)(6) 2013. PATIENT 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
    584354 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR