BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2080318 · Received May 6, 2011

    Report

    Report Number
    1319681-2011-00109
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 7, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 ECI IMMUNODIAGNOSTIC SYSTEM. IN ADDITION, A HIGHER THAN EXPECTED VITROS TROP I ES RESULT WAS OBTAINED WHEN PERFORMING A PRECISION TEST USING A TROPONIN FREE FLUID AS THE SAMPLE. AN OCD FIELD ENGINEER PERFORMED "AS NEEDED" SERVICE TO THE WELL WASH, INCUBATOR, SIGNAL REAGENT AND REAGENT METERING SUBSYSTEMS. PERFORMANCE TESTING FOLLOWING SERVICE VERIFIED THAT THE EQUIPMENT WAS OPERATING AS EXPECTED. THE INVESTIGATION DETERMINED THAT THIS CUSTOMER MAY NOT HAVE PROCESSED SAMPLES IN ACCORDANCE WITH THE TUBE MANUFACTURER'S RECOMMENDATIONS. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE OF THIS EVENT IS AN ANALYZER RELATED ISSUE. HOWEVER, PRE-ANALYTICAL SAMPLE PROCESSING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROP I ES RESULT (0.184 NG/ML) FROM A SINGLE PATIENT SAMPLE PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE AFFECTED PATIENT RESULT WAS NOT REPORTED OUT OF THE LABORATORY, SO NO CORRECTED REPORT WAS REQUIRED. THE REPEAT TROP I ES RESULT (REPEAT = < 0.012 NG/ML) WAS REPORTED FOR THE AFFECTED PATIENT SAMPLE. IN ADDITION, A HIGHER THAN EXPECTED VITROS TROP I ES RESULT (0.018 NG/ML) WAS OBTAINED WHEN PERFORMING A PRECISION TEST USING A TROPONIN FREE FLUID (EXPECTED < 0.014 NG/ML) AS THE SAMPLE. 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 ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1