BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 3832306 · Received February 10, 2014

    Report

    Report Number
    1052693-2014-00044
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    January 9, 2014
    Report Date
    February 10, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LCD FAULT. (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: METER DROPPED/IMPACTED/STRESSED ENOUGH TO BREAK LCD.

    Description of Event or Problem · 1

    CONSUMER CALLED. METER LCD DISPLAY SHOWS PARTIAL CHARACTERS. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87589 TRUEBALANCE BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUEBALANCE NA

    Patients

    Seq Age Sex Outcome Treatment
    1