BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK SMART SYSTEM

    MDR report key: 1172667 · Received September 19, 2008

    Report

    Report Number
    1052693-2008-00065
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 16, 2008
    Manufacturer
    HOEM DIAGNOSTICS INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AN END USER CALLED TO COMPLAIN THAT THE DEVICE KEPT DISPLAYING AN ERROR MESSAGE. PHONE TROUBLE SHOOTING CONFIRMED THE ERROR MESSAGE AND THE DEFECTIVE DEVICE WAS REPLACED FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUETRACK SMART SYSTEM BGM (BLOOD GLUCOSE MONITOR) NBW HOEM DIAGNOSTICS INC. TRUETRACK NA

    Patients

    Seq Age Sex Outcome Treatment
    1