BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3820507 · Received April 9, 2014

    Report

    Report Number
    1052693-2014-00115
    Event Type
    Malfunction
    Date Received
    April 9, 2014
    Date of Event
    October 24, 2013
    Report Date
    April 9, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NIPRO ACKNOWLEDGES THE LATENESS OF THIS REPORT. PRODUCT NOT YET RETURNED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER NORMALLY RANGES 96-101 MG/DL TWO HOURS AFTER MEALS. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (434) AND THE LOWEST NORMAL RESULT (96) IS LOCATED IN ZONE D. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213292 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1412

    Patients

    Seq Age Sex Outcome Treatment
    1