BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2046203 · Received April 8, 2011

    Report

    Report Number
    1319681-2011-00083
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    April 8, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULTS OCCURRED FROM MULTIPLE PATIENT SAMPLES PROCESSED ON THE VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM. THE INVESTIGATION DETERMINED THAT THE SAMPLES IN QUESTION WERE 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 SAMPLES, ALTHOUGH THIS COULD NOT BE CONFIRMED. AN OCD FIELD ENGINEER MADE REPAIRS TO SEVERAL SUB-SYSTEMS INCLUDING THE REAGENT METERING AND WELL WASH SUBSYSTEMS. FOLLOWING THESE ACTIONS, ACCEPTABLE VITROS TROP I ES PERFORMANCE WAS OBSERVED. THE ROOT CAUSE OF THE EVENT IS UNKNOWN. THE POSSIBILITY THAT POOR SAMPLE PROCESSING OR AN ANALYZER RELATED EVENT HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FROM MULTIPLE SAMPLES WHEN PROCESSED ON THE VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE RESULTS WERE REPORTED OUT OF THE LABORATORY HOWEVER CORRECTED REPORTS HAVE BEEN ISSUED. 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 ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1