BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROP I ES REAGENT PACK

    MDR report key: 1063052 · Received June 19, 2008

    Report

    Report Number
    9680658-2008-00183
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 16, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 WS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MFR'S RECOMMENDATION.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSE POSITIVE VITROS TROP I ES OUTLIER RESULTS ON A TWO 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 RESULT WERE 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. NOTE: MDR # 9680658-2008-00182 AND 00183 ARE IDENTICAL. TWO 3500A FORMS ARE BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THE EVENT.

    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 0121

    Patients

    Seq Age Sex Outcome Treatment
    1