BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 3882038 · Received June 18, 2014

    Report

    Report Number
    3004753838-2014-04785
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    DEXCOM INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT DEVICE WAS RETURNED TO DEXCOM AND EVALUATED. THE REPORTED FAILURE WAS NOT CONFIRMED AND NO DEFECT WAS FOUND.

    Description of Event or Problem · 1

    PATIENT'S FATHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM INTERMITTENT AUDIO OUTPUT ON (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED. ADDITIONALLY, AT THE TIME OF THE CALL, DEXCOM TECHNICAL SUPPORT ADVISED PATIENT'S FATHER TO TEST ALERT FUNCTIONALITY AND PATIENT'S FATHER REPORTED ALERTS WERE FUNCTIONAL. DEXCOM HAS ISSUED AN RGA FOR PATIENT TO RETURN THEIR DEVICE TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359267 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS, PRODUCT CODE:MDS MDS DEXCOM INC. MT22430 5120309

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other