BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUETRACK

    MDR report key: 4844491 · Received June 11, 2015

    Report

    Report Number
    1052693-2015-00889
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    April 9, 2015
    Report Date
    June 10, 2015
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K032657
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METER WAS EVALUATED WITH NO DEFECT FOUND. EVALUATION OF THE TEST STRIPS INDICATED THE FINDINGS OF BLACK CHEMISTRY, DUE TO THE BLACK CHEMISTRY, THERE IS A POSSIBILITY OF A "LO" BLOOD RESULT OBTAINED BY THE USER. ROOT CAUSE OF MALFUNCTION NOTED IN THE COMPLAINT IS BLACK CHEMISTRY DUE TO IMPROPER STORAGE.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF E-3 ERROR; RETURNED TEST STRIPS DISPLAYED E-3 IMMEDIATELY WHEN STRIPS WERE INSERTED INTO THE METER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380983 TRUETRACK BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUETRACK RR4347

    Patients

    Seq Age Sex Outcome Treatment
    1