BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3140155 · Received May 29, 2013

    Report

    Report Number
    1052693-2013-00087
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 29, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT THAT METER IS NOT WORKING. NO ADVERSE EVENT REPORTED. CALLER PROVIDED REVIEW OF RESULTS IN MEMORY: 248MG/DL, 227MG/DL, 234MG/DL, 223MG/DL. CALLER BELIEVES THE RESULTS ARE NOT ACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236898 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RM3544

    Patients

    Seq Age Sex Outcome Treatment
    1