BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUE RESULT

    MDR report key: 3022959 · Received March 21, 2013

    Report

    Report Number
    1052693-2013-00021
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 21, 2013
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF INACCURATE RESULTS BASED ON EMERGENCY ROOM DR. FEEDBACK. RESULTS IN MEMORY 429, 345, 447, 409. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118211 TRUE RESULT BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. TRUERESULT TN2624

    Patients

    Seq Age Sex Outcome Treatment
    1