BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE TRACK

    MDR report key: 3802502 · Received February 21, 2014

    Report

    Report Number
    1052693-2014-00142
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 9, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 200-220MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT GIVEN (413) AND THE NORMAL RESULT (200) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111672 TRUE TRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RP4304

    Patients

    Seq Age Sex Outcome Treatment
    1