BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM

    MDR report key: 4770382 · Received May 13, 2015

    Report

    Report Number
    3004753838-2015-31011
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 16, 2015
    Report Date
    April 16, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. THE RECEIVER LOG WAS REVIEWED AND NO ISSUES RELATED TO THE CUSTOMER COMPLAINT WERE FOUND. FUNCTIONAL TESTING WAS PERFORMED ON THE DEVICE AND NO FAILURES RELATED TO THE CUSTOMER COMPLAINT WERE FOUND. THE DEVICE WAS DETERMINED TO BE WORKING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION. THEREFORE, THE CUSTOMER COMPLAINT OF LOW AUDIO OUTPUT COULD NOT BE CONFIRMED, AND A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311945 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM, DEXCOM SHARE SYSTEM MDS MDS DEXCOM, INC. MT22495-PNK 5197942

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR