BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3832305 · Received February 10, 2014

    Report

    Report Number
    1052693-2014-00045
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 9, 2014
    Report Date
    February 10, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT LOW BLOOD RESULTS. PERFORMED BLOOD TEST-47MG/DL. CALLER STATES SHE NORMALLY READS BETWEEN 80-100MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT IN MEMORY (47) AND THE NORMAL RESULT (100) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87769 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1402

    Patients

    Seq Age Sex Outcome Treatment
    1