BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1545017 · Received November 12, 2009

    Report

    Report Number
    1319681-2009-00360
    Event Type
    Malfunction
    Date Received
    November 12, 2009
    Date of Event
    September 15, 2009
    Report Date
    October 14, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT, IN ADDITION TO THE PROFICIENCY FLUID RESULTS, RESULTS FOR BOTH VITROS AND NON-VITROS QUALITY CONTROL FLUIDS USING VITROS GENT REAGENT LOT # 1512-06-8755 WERE NEGATIVELY BIASED. THE ROOT CAUSE OF THIS EVENT WAS DETERMINED TO BE USER ERROR AS THE CUSTOMER HAD NOT PROPERLY VERIFIED THE VITROS GENT CALIBRATION IN USE AT THE TIME THE PROFICIENCY FLUIDS WERE PROCESSED. FOLLOWING RE-CALIBRATION OF VITROS GENT REAGENT LOT # 1512-06-08755, ACCEPTABLE QUALITY CONTROL AND PROFICIENCY FLUID RESULTS WERE OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NEGATIVELY BIASED PROFICIENCY FLUID RESULTS PROCESSED USING VITROS GENT REAGENT ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PT SAMPLES WERE NOT AFFECTED AS ONLY QUALITY CONTROL AND PROFICIENCY FLUIDS WERE TESTED DURING THE EVENT. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1