BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3980290 · Received June 5, 2014

    Report

    Report Number
    1052693-2014-00156
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 5, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 LOW BLOOD RESULTS. CALLER NORMALLY IS 100MG/DL 2 HOURS AFTER DINNER. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (60) AND THE NORMAL RESULT (100) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329859 TRUERESULT BLOOD GLUCOSE SYS NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PR1782

    Patients

    Seq Age Sex Outcome Treatment
    1