BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4223681 · Received August 5, 2014

    Report

    Report Number
    1052693-2014-00231
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 10, 2014
    Report Date
    August 4, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED PRODUCT SOWS SOME LCD CHARACTERS MISSING, WHICH MAY CAUSE INCORRECT INTERPRETATION OF METER RESULTS. 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
    456351 TRUETRACK BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUETRACK RP4253

    Patients

    Seq Age Sex Outcome Treatment
    1