BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 2042607 · Received April 6, 2011

    Report

    Report Number
    1319681-2011-00076
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    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 ECIQ IMMUNODIAGNOSTIC SYSTEM. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIVITIES INCLUDING CLEANING OF THE INCUBATOR. FOLLOWING THESE ACTIONS, ACCEPTABLE VITROS TROP I ES PERFORMANCE WAS OBSERVED. IN ADDITION, 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. 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 RESULT FROM ONE PATIENT SAMPLE WHEN PROCESSED ON THE VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. CONFLICTING INFORMATION WAS PROVIDED IN REGARDS TO WHETHER THE RESULT WAS NOT REPORTED OUT OF THE LABORATORY OR NOT. 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