BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1951072 · Received January 6, 2011

    Report

    Report Number
    1319681-2011-00004
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 27, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT OCCURRED WHILE USING THE VITROS ECIQ ANALYZER. THE INVESTIGATION CONFIRMED THAT THE SAMPLE INVOLVED WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATION. IT IS LIKELY THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. AN OCD FIELD ENGINEER PERFORMED "AS NEEDED" MAINTENANCE TO THE WELL WASH AND REAGENT METERING SUBSYSTEMS. PERFORMANCE TESTS VERIFIED THAT THE INSTRUMENT WAS OPERATING AS EXPECTED. A DEFINITIVE ROOT CAUSE OF THIS EVENT COULD NOT BE DETERMINED, HOWEVER, AN INSTRUMENT RELATED ISSUE AND/OR PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT ON ONE PATIENT SAMPLE WHILE USING THE VITROS ECIQ IMMUNODIAGNOSTIC ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE ORIGINAL RESULT WAS NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO THE PATIENT 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 ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1