BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS BARB REAGENT PACK

    MDR report key: 1070009 · Received July 2, 2008

    Report

    Report Number
    1319808-2008-00203
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    February 29, 2008
    Report Date
    June 3, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THE VITROS 5, 1 AND VITROS BARB REAGENT WERE OPERATING AS INTENDED. THE INVESTIGATION DETERMINED THAT THE PROFICIENCY SAMPLE PRODUCED A VITROS BARB RESULT OF 258 NG/ML WHICH WAS VERY CLOSE TO THE THEORETICAL CONCENTRATION. HOWEVER, IT WAS LESS THAN THE QUALITATIVE CUTOFF OF 300 NG/ML IN USE BY THE CUSTOMER AND WAS REPORTED AS NEGATIVE. ANY RESULT OTHER THAN POSITIVE WAS GRADED AS A FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A FALSE NEGATIVE PROFICIENCY RESULT USING VITROS BARB REAGENT ON THE VITROS 5, 1 FS CHEMISTRY SYSTEM. THE WEIGHED IN AMOUNT OF AMOBARBITOL WAS EXPECTED TO PRODUCE A POSITIVE RESULT. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS THE SAMPLE INVOLVED WAS A PROFICIENCY SAMPLE, AND NOT A PT SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS BARB REAGENT PACK IN-VITRO DIAGNOSTIC DIS ORTHO-CLINICAL DIAGNOSTICS NA 1522-01-7678

    Patients

    Seq Age Sex Outcome Treatment
    1