BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3811164 · Received March 24, 2014

    Report

    Report Number
    1052693-2014-00102
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 26, 2014
    Report Date
    March 24, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. BACK TO BACK BLOOD TEST RESULTS WERE 189MG/DL AND 393MG/DL. NO ADVERSE EVENT REPORTED. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THESE TWO RESULTS IS IN THE ZONE B/C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172901 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT RP1654

    Patients

    Seq Age Sex Outcome Treatment
    1