BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3622646 · Received December 12, 2013

    Report

    Report Number
    1052693-2013-00379
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    October 23, 2013
    Report Date
    December 12, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    CGA
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NIPRO DIAGNOSTICS, INC. ACKNOWLEDGES THE LATENESS OF THIS REPORT. LCD FAULT. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER ERROR. (B)(4).

    Description of Event or Problem · 1

    CONSUMER CALLED. METER SHOWING E-1 ERROR. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651543 TRUERESULT BLOOD GLUCOSE SYSTEM CGA NIPRO DIAGNOSTICS, INC. TRUERESULT NA

    Patients

    Seq Age Sex Outcome Treatment
    1