BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4093862 · Received September 16, 2014

    Report

    Report Number
    3004753838-2014-29229
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    November 16, 2013
    Report Date
    November 17, 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 CUSTOMER COMPLAINT WAS CONFIRMED. THIS COMPLAINT WAS DEEMED REPORTABLE UPON COMPLETION OF DEVICE EVALUATION ON (B)(4) 2014. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE COMPONENT IN THE RECEIVER'S PRINTED CIRCUIT BOARD.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2013 TO REPORT A HARDWARE ERROR MESSAGE PATIENT EXPERIENCED 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
    571613 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR