BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4241731 · Received November 10, 2014

    Report

    Report Number
    3004753838-2014-29525
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    June 1, 2014
    Report Date
    June 1, 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 RETURNED COMPLAINT DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A REVIEW OF THE RECEIVER DATA LOG CONFIRMED A HARDWARE ERROR CODE. THIS COMPLAINT WAS DEEMED REPORTABLE UPON COMPLETION OF DEVICE EVALUATION ON 10/14/2014. THE ROOT CAUSE WAS DETERMINED TO BE A HARDWARE COMPONENT FAILURE.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(4) 2014 TO REPORT THAT ON (B)(6) 2014, RECEIVER VIBRATES CONTINUOUSLY. PATIENT STATED "RECEIVER DROPPED OUT OF THE CASE INTO TUB". 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
    723264 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR