BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC ANALYZER

    MDR report key: 1710391 · Received June 4, 2010

    Report

    Report Number
    1319681-2010-00110
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 7, 2010
    Report Date
    July 21, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS TROP I ES AND B-HCG II RESULTS OCCURRED WHILE USING THE VITROS ECIQ ANALYZER. THE INVESTIGATION CONFIRMED THAT THE ROOT CAUSE OF THIS EVENT WAS INSTRUMENT RELATED. HOWEVER, USER ERROR CONTRIBUTED TO THE CONTAMINATION OF A SINGLE BOTTLE OF VITROS UNIVERSAL WASH REAGENT PLACED ON THE VITROS ECIQ SYSTEM. AN OCD FIELD ENGINEER FOUND THAT CLEANING OF THE FLUIDICS SUBSYSTEM WAS NECESSARY TO RETURN THE INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THIS CUSTOMER OBTAINED UNEXPECTED HIGH VITROS TROP I ES AND B-HCG II RESULTS FROM DIFFERENT PATIENT SAMPLES AND FROM QUALITY CONTROL SAMPLES PROCESSED ON A VITROS ECIQ IMMUNODIAGNOSTIC ANALYZER. THE SAME SAMPLES PRODUCED EXPECTED TROP I ES AND B-HCG II RESULTS WHEN PROCESSED ON AN ALTERNATE VITROS ECI SYSTEM. RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE INITIALLY HIGH RESULTS WERE NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF HARM TO THE PATIENTS 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 ANALYZER IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1