BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 3811185 · Received March 24, 2014

    Report

    Report Number
    1052693-2014-00106
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    March 3, 2014
    Report Date
    March 24, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT YET RETURNED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CALLER NORMALLY RANGES FROM 70-101MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (210) AND THE LOWEST NORMAL RESULT (70) IS LOCATED IN ZONE C/D. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172897 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE BP4297

    Patients

    Seq Age Sex Outcome Treatment
    1