BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3832326 · Received February 10, 2014

    Report

    Report Number
    1052693-2014-00053
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 16, 2014
    Report Date
    February 10, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. BACK TO BACK BLOOD TESTS PERFORMED WERE 135 AND 439 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE TWO RESULTS IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87904 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RP4257

    Patients

    Seq Age Sex Outcome Treatment
    1