BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1792082 · Received August 10, 2010

    Report

    Report Number
    1319681-2010-00159
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 12, 2010
    Report Date
    August 10, 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

    RELEVANT ANALYZER DATA LOGGER FILES WERE REVIEWED AND IDENTIFIED UNEXPECTED PERFORMANCE OF MULTIPLE ANALYZER MODULES OF THE VITROS ECIQ SYSTEM. SERVICE ACTIONS WERE TAKEN TO RETURN THE SYSTEM TO EXPECTED OPERATION WITH NO RECURRENCE OF NON-REPRODUCIBLE HIGHER THAN EXPECTED RESULTS. THE INVESTIGATION CONCLUDES THE ROOT CAUSE OF THE HIGHER THAN EXPECTED VITROS B-HCG RESULT WAS ANALYZER RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A NON-REPRODUCIBLE HIGHER THAN EXPECTED TOTAL B-HCG RESULT FROM A PATIENT SAMPLE USING VITROS TOTAL B-HCG II REAGENT ON A VITROS ECIQ SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE HIGHER THAN EXPECTED VITROS B-HCG PATIENT RESULT WAS NOT REPORTED FROM THE LABORATORY. 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 KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1