BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5221072 · Received November 12, 2015

    Report

    Report Number
    3004753838-2015-73160
    Event Type
    Malfunction
    Date Received
    November 12, 2015
    Date of Event
    October 18, 2015
    Report Date
    October 18, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751025 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649-PNK 5197595

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR