BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    MDR report key: 5212969 · Received November 9, 2015

    Report

    Report Number
    3004753838-2015-66433
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 15, 2015
    Report Date
    October 15, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM ON (B)(6) 2015 TO REPORT NO AUDIO OUTPUT ON (B)(6) 2015. AT THE TIME OF CONTACT THE PATIENT'S MOTHER DID NOT REPORT ANY INJURY OR MEDICAL INTERVENTION. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETE.

    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
    742107 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22608-PNK 5202415

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR