BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6760779 · Received August 2, 2017

    Report

    Report Number
    3004753838-2017-42999
    Event Type
    Malfunction
    Date Received
    August 2, 2017
    Date of Event
    July 10, 2017
    Report Date
    July 13, 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 07/13/2017 THAT ON (B)(6) 2017 THE RECEIVER HAD INTERMITTENT AUDIO OUTPUT. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT 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 BOOT AND CHARGE. THE DOWNLOAD LOGS DOES NOT CONTAIN ANY ERRORS. RECEIVER PASSED ALL TESTS ON FUNCTIONAL TEST STATION EQ-900302-011.(PASSED AUDIO TEST). PASSED 'TRY IT', 'FIXED LOW' TEST. AUDIO TONE WAS HEARD AT NORMAL VOLUME WHEN TESTED WITH RECEIVER COMMUNICATION TOOL: 7.0.0.75 (LOW, MEDIUM, HIGH). OPENED RECEIVER, PASSED INTERNAL VISUAL INSPECTION. SPEAKER MEASURED 7.45 OHMS.(WITHIN TOLERANCE). PASSED 'WIGGLE' TEST. THE REPORTED EVENT OF AN INTERMITTENT AUDIO OUTPUT WAS NOT CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542478 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT20649-1 5223609

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR