BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROP I ES REAGENT PACK

    MDR report key: 1122791 · Received August 13, 2008

    Report

    Report Number
    9680658-2008-00237
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE VITROS ECI WAS OPERATING AS INTENDED. THE ROOT CAUSE FOR THE UNEXPECTED TROP I ES RESULT IS UNK. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE SAMPLE ALTHOUGH THIS COULD NOT BE CONFIRMED. IT WAS CONFIRMED THAT THE SAMPLE INVOLVED WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE, FALSE POSITIVE VITROS TROP I ES RESULTS ON A PT SAMPLE ON THE VITROS ECI ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE INITIAL TROP I ES PT RESULTS WAS NOT REPORTED TO THE CLINICIAN. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. THE 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 0180

    Patients

    Seq Age Sex Outcome Treatment
    1