BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROP I ES REAGENT PACK

    MDR report key: 1161470 · Received September 11, 2008

    Report

    Report Number
    9680658-2008-00273
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 14, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    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 TROP I ES REAGENT AND VITROS ECI SYSTEM WERE OPERATING AS INTENDED. THE INVESTIGATION DETERMINED THAT THE CUSTOMER IS NOT FOLLOWING THE SAMPLE COLLECTION TUBE MANUFACTURER'S RECOMMENDATIONS FOR CENTRIFUGATION TIME AND SPEED. THE VITROS TROP I ES INSTRUCTIONS FOR USE, "SPECIMEN COLLECTION AND PREPARATION" SECTION STATES THAT "SAMPLES SHOULD BE THOROUGHLY SEPARATED FROM ALL CELLULAR MATERIAL. FAILURE TO DO SO MAY LEAD TO AN ERRONEOUS RESULT." THE ROOT CAUSE OF THE FALSELY ELEVATED RESULTS IS MOST LIKELY USER ERROR ASSOCIATED WITH PRE-ANALYTICAL SAMPLE PROCESSING.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSELY ELEVATED, NON-REPRODUCIBLE VITROS TROP I ES RESULTS ON TWO DIFFERENT PATIENT SAMPLES. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSELY ELEVATED RESULTS WERE NOT REPORTED AND THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. NOTE: THIS FORM 3500A (MDR # 9680658-2008-00273) IS ONE OF TWO MDRS FOR THIS EVENT. TWO DEVICES WERE INVOLVED. TWO PATIENT SAMPLES WERE ASSAYED USING A SINGLE TROP I ES REAGENT LOT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROP I ES REAGENT PACK IN-VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS NA 0220

    Patients

    Seq Age Sex Outcome Treatment
    1