BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 3811184 · Received March 24, 2014

    Report

    Report Number
    1052693-2014-00105
    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 108-110MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE HIGHEST RESULT IN MEMORY (348) AND THE LOWEST NORMAL RESULT (108) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172377 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE BP4200

    Patients

    Seq Age Sex Outcome Treatment
    1