BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3820505 · Received April 9, 2014

    Report

    Report Number
    1052693-2014-00111
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 9, 2014
    Manufacturer
    NIPRO DIAGNOSTICS INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT NOT YET RETURNED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. CUSTOMER NORMALLY IS 120-130 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT GIVEN (248) AND THE NORMAL RESULT (120) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213302 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS INC. TRUETRACK RP4244

    Patients

    Seq Age Sex Outcome Treatment
    1