BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 3022960 · Received March 21, 2013

    Report

    Report Number
    1052693-2013-00020
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 24, 2013
    Report Date
    March 21, 2013
    Manufacturer
    NIPRO DIAGNOSTICS INC
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT YET RETURNED FOR EVAL. (B)(4).

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ERRATIC BLOOD RESULTS. BACK TO BACK BLOOD TEST RESULTS WERE 503MG/DL AND 351MG/DL ON TWO DIFFERENT TEST STRIP LOTS. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118269 TRUERESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS INC TRUERESULT TN2650, TN2705

    Patients

    Seq Age Sex Outcome Treatment
    1