BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3021258 · Received March 21, 2013

    Report

    Report Number
    1052693-2013-00027
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 15, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVALUATION. INTERNAL REPORT #(B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF HIGH BLOOD RESULTS. RESULTS OF 227, 284, 200, 273MG/DL. CALLER STATES A CONTROL TEST SHOWED RESULT IN RANGE. NO ADVERSE EVENT REPORTED. CALLER WANTED METER REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117496 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT TN2476

    Patients

    Seq Age Sex Outcome Treatment
    1