BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2983586 · Received February 28, 2013

    Report

    Report Number
    1319681-2013-00054
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES PATIENT RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES WHILE USING THE VITROS 5600 SYSTEM. THERE IS NO EVIDENCE TO SUGGEST THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN OCD FILED ENGINEER PERFORMED SERVICE ACTIONS TO MULTIPLE SUBSYSTEMS OF THE ANALYZER TO OBTAIN ACCEPTABLE PERFORMANCE. ADDITIONALLY, THE SAMPLE 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. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS ANALYZER RELATED. ADDITIONALLY, A PRE-ANALYTICAL SAMPLE PROCESSING ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (PATIENT A RESULT = 0.535 VS. AN EXPECTED RESULT < 0.012 NG/ML; PATIENT B RESULT = 0.37 VS. AN EXPECTED RESULT = 0.013 NG/ML) FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS 5600 SYSTEM. THE AFFECTED PATIENT A RESULT WAS REPORTED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE CUSTOMER RETESTED PATIENT A SAMPLE AND THE CLINICIAN QUESTIONED THE RESULT. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. NO TREATMENT WAS GIVEN, CHANGED, OR WITHHELD BASED ON THE AFFECTED RESULT FOR PATIENT A. THE AFFECTED PATIENT B RESULT WAS IDENTIFIED PRIOR TO REPORTING. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87074 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1