BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 2071064 · Received April 27, 2011

    Report

    Report Number
    3007111389-2011-00040
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 27, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULTS OCCURRED FROM TWO PATIENT SAMPLE PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE POSSIBILITY THAT POOR SAMPLE PROCESSING, HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT. THE INVESTIGATION DETERMINED THAT THE SAMPLES IN QUESTION WERE NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE INVESTIGATION DETERMINED THAT THE VITROS ECI WAS OPERATING AS INTENDED. THE ROOT CAUSE FOR THE UNEXPECTED TROP I ES RESULT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT FROM TWO PATIENT SAMPLE WHEN PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. ONE OF THE TWO RESULTS WAS REPORTED OUT OF THE LABORATORY. A CORRECTED REPORT WAS ISSUED FOR THE RESULT REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4). THIS REPORT IS 1 OF 2 3500A FORMS BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN VITRO DIAGNOSTIC MMI ORTHO-CLINICAL DIAGNOSTICS 0576

    Patients

    Seq Age Sex Outcome Treatment
    1