BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3231765 · Received July 15, 2013

    Report

    Report Number
    1052693-2013-00122
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 3, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. BLOOD TEST PERFORMED (FASTING WITH NO MEDICATION) AT 7:10A WAS 386 MG/DL. CALLER BELIEVES HER RESULTS SHOULD BE BETWEEN 120 AND 130 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE RESULT PERFORMED AT THE TIME OF THE CALL AND THE LOWEST EXPECTED RESULT (120MG/DL) IS IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326765 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PN1002, PP1254

    Patients

    Seq Age Sex Outcome Treatment
    1