BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5221077 · Received November 12, 2015

    Report

    Report Number
    3004753838-2015-66538
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    October 16, 2015
    Report Date
    October 19, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS EXTERNALLY VISUALLY INSPECTED AND NO DEFECT WAS FOUND. A REVIEW OF THE DOWNLOADED RECEIVER LOG DID NOT FIND ANY ISSUES RELATED TO THE CUSTOMER COMPLAINT. FUNCTIONAL TESTING AND A MANUAL DROP TEST FOR INTERMITTENCY WAS PERFORMED AND THE TESTS FAILED. THE RECEIVER CASE WAS OPENED FOR FURTHER EVALUATION. A VISUAL INTERIOR INSPECTION WAS PERFORMED AND THE INSPECTION PASSED. A SPEAKER RESISTANCE TEST WAS PERFORMED AND CONFIRMED THE REPORTED EVENT OF NO AUDIO OUTPUT. THE ROOT CAUSE WAS DETERMINED TO BE A DEFECTIVE SPEAKER ASSEMBLY.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT THAT ON (B)(6) 2015, PATIENT EXPERIENCED NO AUDIO OUTPUT. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749666 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649 5197603

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR