BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 1871347 · Received October 15, 2010

    Report

    Report Number
    3007111389-2010-00008
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 17, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE FALSELY ELEVATED VITROS TROP I ES RESULTS OCCURRED ON THREE DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION DID NOT FIND ANY EVIDENCE THE VITROS 5600 SYSTEM OR VITROS TROPI ES REAGENT MALFUNCTIONED. THE POSSIBILITY THAT POOR SAMPLE PROCESSING, HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT. THE INVESTIGATION COULD NOT CONFIRM THAT THE SAMPLES IN QUESTION WERE 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.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NON-REPEATABLE HIGHER THAN EXPECTED VITROS TROPI ES RESULTS ON SAMPLES FROM THREE DIFFERENT PATIENT SAMPLES PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND ONE PATIENT WAS TREATED BASED ON THE REPORTED RESULT. CORRECTED REPORTS WAS ISSUED THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (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 0560

    Patients

    Seq Age Sex Outcome Treatment
    1