BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3896070 · Received May 20, 2014

    Report

    Report Number
    1052693-2014-00145
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 20, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS 117MG/DL OR A LITTLE ABOVE. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (25) AND THE NORMAL RESULT (117) IS LOCATED IN ZONE B/D. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299646 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC TRUERESULT PP1677

    Patients

    Seq Age Sex Outcome Treatment
    1