BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6875886 · Received September 19, 2017

    Report

    Report Number
    3004753838-2017-68832
    Event Type
    Malfunction
    Date Received
    September 19, 2017
    Date of Event
    August 17, 2017
    Report Date
    August 23, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2017 THAT ON (B)(6) 2017 THE RECEIVER HAD NO AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORTED NO AUDIO OUTPUT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. THE RECEIVER WILL CHARGE AND BOOT. THE RECEIVER LOG CONTAINS NO ERROR RELATED TO CUSTOMER COMPLAINT. .OPENED RECEIVER,PASSED INTERNAL VISUAL INSPECTION. RECEIVER FAILED AUDIO TEST ON FUNCTIONAL TEST STATION EQ-900302-011. FAILED. 'TRY IT', 'FIXED LOW' TEST. (NO AUDIO WAS HEARD.). AUDIO TONE WAS NOT HEARD WHEN TESTED WITH RECEIVER COMMUNICATION TOOL. THE REPORTED EVENT OF NO AUDIO OUTPUT WAS CONFIRMED. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655482 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT20649-1 5222392

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR