BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 1871329 · Received October 15, 2010

    Report

    Report Number
    3007111389-2010-00009
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULTS OCCURRED ON FIVE PATIENT SAMPLES WHEN PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE POSSIBILITY THAT POOR SAMPLE PROCESSING HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT. THE INVESTIGATION COULD NOT CONFIRM THAT THE SAMPLE IN QUESTION WAS PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, MAY HAVE BEEN PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT ON SAMPLES FROM FIVE DIFFERENT PATIENTS WHEN PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND ONE PATIENT WAS TREATED BASED ON THE RESULT. CORRECTED REPORTS WERE ISSUED FOR ALL FIVE SAMPLES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    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 562

    Patients

    Seq Age Sex Outcome Treatment
    1