BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1974564 · Received January 31, 2011

    Report

    Report Number
    1319681-2011-00027
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 31, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROP I ES RESULTS WERE OBTAINED WHILE USING THE VITROS 5600 ANALYZER. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. AN OCD FIELD ENGINEER FOUND THAT 'AS NEEDED' MAINTENANCE TO THE MICROWELL INCUBATOR AND WELL WASH METERING SUBSYSTEMS WERE REQUIRED TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. PERFORMANCE TESTS CONFIRMED THAT THE INSTRUMENT WAS OPERATING AS INTENDED WITH NO RECURRENCE OF THE EVENT.

    Description of Event or Problem · 1

    THIS CUSTOMER OBTAINED NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES PATIENT RESULTS WHILE USING THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO THE PATIENTS 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 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1