BEUDAMED
    FDA Adverse Event Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1934796 · Received December 21, 2010

    Report

    Report Number
    1319681-2010-00285
    Date Received
    December 21, 2010
    Date of Event
    November 2, 2010
    Report Date
    December 21, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NON REPRODUCIBLE FALSELY ELEVATED TROP I ES RESULTS OCCURRED ON MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM REQUIRED SERVICING (INCUBATOR AND MULTIPLE ADJUSTMENTS). IN ADDITION, THE INVESTIGATION COULD NOT DETERMINE WHETHER THE SAMPLES IN QUESTION WERE PROCESSED 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 ROOT CAUSE OF THE EVENT IS INSTRUMENT RELATED HOWEVER THE POSSIBILITY THAT POOR SAMPLE PROCESSING HAD CONTRIBUTED TO THE RESULTS COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NON REPRODUCIBLE HIGHER THAN EXPECTED VITROS TROP I ES RESULTS FROM MULTIPLE PATIENT SAMPLES WHEN PROCESSED ON THE VITROS ECI IMMUNODIAGNOSTIC SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. IT IS UNKNOWN WHETHER OR NOT THE AFFECTED RESULTS WERE REPORTED OUT OF THE LABORATORY OR IF CORRECTED REPORTS WERE ISSUED. 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
    1 VITROS ECI IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1