BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 4130290 · Received September 30, 2014

    Report

    Report Number
    3004753838-2014-25577
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    January 4, 2014
    Report Date
    January 4, 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). DURING COMPLAINT REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT IS A REPORTABLE EVENT. PROBLEM COULD NOT BE CONFIRMED BECAUSE PRODUCT/DATA IS NOT AVAILABLE. THE ROOT CAUSE CANNOT BE DETERMINED-NO PRODUCT/DATA.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2014 TO CLAIM LOW AUDIO OUTPUT PATIENT EXPERIENCED ON (B)(6) 2014. AT THE TIME OF THE CALL TO DEXCOM TECHNICAL SUPPORT, NO MEDICAL INTERVENTION OR INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607869 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. MT20649

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR