BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2200719 · Received August 11, 2011

    Report

    Report Number
    1319681-2011-00161
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS WERE OBTAINED FROM FIVE PATIENT SAMPLES PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. RESULTS OF PRECISION TESTING DEMONSTRATED THAT THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM WAS NOT PERFORMING AS EXPECTED AT THE TIME OF THE EVENT. AN OCD FIELD ENGINEER MADE MULTIPLE REPAIRS AND ADJUSTMENTS TO THE MICROWELL INCUBATOR, REAGENT METERING, AND WELL WASH SUBSYSTEMS. HOWEVER, ACCEPTABLE VITROS TROP I ES PERFORMANCE HAS NOT YET BEEN ACHIEVED, AND THE INVESTIGATION IS ONGOING. IN ADDITION, IT IS UNKNOWN IF THE FIRST PATIENT SAMPLE WAS PROCESSED IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE FIRST SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. A DEFINITIVE ROOT CAUSE HAS NOT BEEN DETERMINED AS THE INVESTIGATION IS ONGOING. HOWEVER, THE EVENT IS MOST LIKELY INSTRUMENT RELATED. PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS AN ADDITIONAL CONTRIBUTING FACTOR FOR THE FIRST PATIENT SAMPLE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON-REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS (0.138, 0.320, 0.136, 0.095, AND 0.095 NG/ML) FROM FIVE PATIENT SAMPLES PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER THAN EXPECTED RESULTS WERE INITIALLY REPORTED OUT OF THE LABORATORY FOR TWO OF THE PATIENT SAMPLES. HOWEVER, CORRECTED REPORTS (ALL VALUES < 0.012 NG/ML) WERE ISSUED FOR ALL AFFECTED PATIENT SAMPLES 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 ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1