BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2200723 · Received August 11, 2011

    Report

    Report Number
    1319681-2011-00162
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. EVALUATION OF THE SYSTEM DEMONSTRATED UNACCEPTABLE VITROS TROP I ES PRECISION. AN OCD FIELD ENGINEER MADE REPAIRS TO THE FLUIDICS, WELL WASH, AND INCUBATOR SUBSYSTEM TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. FOLLOWING THIS ACTION, ACCEPTABLE VITROS TROP I ES PERFORMANCE WAS OBSERVED. IN ADDITION, THE INVESTIGATION DETERMINED THAT THE SAMPLE IN QUESTION WAS NOT PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE ROOT CAUSE OF THIS EVENT IS MOST LIKELY INSTRUMENT RELATED. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS AN ADDITIONAL CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULT (0.85 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER THAN EXPECTED RESULT WAS INITIALLY REPORTED OUT OF THE LABORATORY. HOWEVER, THE RESULT WAS QUESTIONED BY A PHYSICIAN AND A CORRECTED REPORT (0.028 NG/ML) WAS ISSUED UPON REPEAT ANALYSIS. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT NUMBER (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1