BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3515299 · Received December 6, 2013

    Report

    Report Number
    1052693-2013-00360
    Event Type
    Malfunction
    Date Received
    December 6, 2013
    Date of Event
    October 24, 2013
    Report Date
    November 25, 2013
    Manufacturer
    NIRO DIAGNOSTICS INC
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT LOW BLOOD RESULTS. LOWEST BLOOD TEST IN MEMORY - 60 MG/DL. CALLER STATES HE NORMALLY RANGES FROM 120-135 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT IN MEMORY (60) AND THE HIGHEST NORMAL RESULT (135) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633737 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIRO DIAGNOSTICS INC TRUERESULT PP1478

    Patients

    Seq Age Sex Outcome Treatment
    1