BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 3802483 · Received February 21, 2014

    Report

    Report Number
    1052693-2014-00143
    Event Type
    Malfunction
    Date Received
    February 21, 2014
    Date of Event
    April 21, 2014
    Report Date
    May 20, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TEST STRIPS RECEIVED SHOWED NO/VERY LIGHT CHEMISTRY DEPOSIT, WHICH WOULD LEAD TO "LO" RESULTS BEING OBTAINED ON THE METER. MOST LIKELY UNDERLYING ROOT CAUSE IS MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT "LO" BLOOD RESULTS. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109990 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUTRACK RP4162

    Patients

    Seq Age Sex Outcome Treatment
    1