BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4841024 · Received June 12, 2015

    Report

    Report Number
    3004753838-2015-31315
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION. THE DEVICE PASSED EXTERIOR VISUAL INSPECTION AS WELL AS THE MANUAL SOUND DROP TEST. A REVIEW OF THE RECEIVER DATA LOG FOUND NO ERRORS RELATED TO THE INCIDENT. GLOBAL RECEIVER FUNCTIONAL TESTING RESULTED IN NO FAILURES RELATED TO THE CUSTOMER COMPLAINT. THE REPORTED FAULT COULD NOT BE REPRODUCED. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. AN INTERIOR INSPECTION WAS PERFORMED AND THE INSPECTION PASSED. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ISSUES RELATED TO THE CUSTOMER COMPLAINT. FUNCTIONAL TESTING AND A MANUAL DROP TEST WAS PERFORMED AND THE TESTS FAILED, CONFIRMING THE REPORTED EVENT OF NO AUDIO OUTPUT. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT NO AUDIO OUTPUT FROM THE RECEIVER THAT OCCURRED ON (B)(6) 2015. 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
    385232 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5167424

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR