BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1873407 · Received October 19, 2010

    Report

    Report Number
    1319681-2010-00226
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 18, 2010
    Report Date
    October 19, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT OCCURRED FROM ONE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. AN OCD FIELD ENGINEER PERFORMED PERIODIC MAINTENANCE AND ADJUSTED THE INCUBATOR AND WELL WASH SUBSYSTEMS TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. FOLLOWING THESE ACTIONS, ACCEPTABLE VITROS TROP I ES PERFORMANCE WAS OBSERVED. THE INVESTIGATION ALSO DETERMINED THAT THE SAMPLE IN QUESTION WAS 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 SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, PRE ANALYTICAL SAMPLE PROCESSING OR AN ANALYZER RELATED EVENT CANNOT BE RULED OUT AS CONTRIBUTING FACTORS. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT FROM ONE PATIENT SAMPLE WHEN PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULT WAS REPORTED OUT OF 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5600 INTEGRATED SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1