BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2923242 · Received January 18, 2013

    Report

    Report Number
    1319681-2013-00034
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 18, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT TWO NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FROM TWO DIFFERENT PATIENT SAMPLES RUN ON THE VITROS 5600 SYSTEM. THERE WAS NO EVIDENCE TO SUGGEST THAT A REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT. AN OCD FIELD ENGINEER REPLACED THE FINAL WELL WASH LEVEL SENSE CABLE TO RETURN THE ANALYZER TO EXPECTED 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 ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE ANALYZER RELATED. HOWEVER, 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 1= 0.593 VS. EXPECTED RESULT <0.012 NG/ML AND PATIENT 2=1.27 VS. EXPECTED RESULT <0.012 NG/ML) FROM TWO DIFFERENT PATIENT SAMPLES PROCESSED ON THE VITROS 5600 SYSTEM. THE HIGHER THAN EXPECTED PATIENT RESULTS WERE NOT REPORTED FROM THE LABORATORY. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. HOWEVER, THE PHYSICIAN QUESTIONED THE AFFECTED PATIENT RESULTS AND THE CUSTOMER RETESTED THE SAMPLES. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27964 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1