BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUEBALANCE

    MDR report key: 1961687 · Received December 28, 2010

    Report

    Report Number
    1052693-2010-00069
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 28, 2010
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K090495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LCD FAULT. (B)(4).

    Description of Event or Problem · 1

    CONSUMER CALLED. METER LCD DISPLAYING PARTIAL CHARACTERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1