BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUERESULT

    MDR report key: 4223609 · Received August 5, 2014

    Report

    Report Number
    1052693-2014-00249
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 27, 2014
    Report Date
    August 5, 2014
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    LFR
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE APOLOGIZE FOR THE LATENESS OF THIS REPORT. PRODUCT NOT YET RETURNED.

    Description of Event or Problem · 1

    CONSUMER COMPLAINT OF ABOUT HIGH BLOOD RESULTS. CUSTOMER SAYS DOCTOR HAS GIVEN HIM A GOAL OF 180-200MG/DL. HE HAS BEEN GETTING RESULTS IN THE 400'S. UNABLE TO ACCESS MEMORY OF METER TO CONFIRM. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN A 400 MG/DL RESULT AND THE LOWEST NORMAL RESULT (180) IS LOCATED IN ZONE C. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458401 TRUERESULT BLOOD GLUCOSE SYSTEM LFR NIPRO DIAGNOSTICS, INC. TRUERESULT PR1795

    Patients

    Seq Age Sex Outcome Treatment
    1