BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3896059 · Received May 20, 2014

    Report

    Report Number
    1052693-2014-00149
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 22, 2014
    Report Date
    May 20, 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

    LCD FAULT, INTERNAL REPORT # (B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: METER DROPPED/IMPACTED/STRESSED ENOUGH TO BREAK LCD; POOR SOLDER CONNECTION ON 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
    299645 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT PP1209

    Patients

    Seq Age Sex Outcome Treatment
    1