BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1840844 · Received September 22, 2010

    Report

    Report Number
    1319681-2010-00201
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 22, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE EVENT WAS RELATED IN INSTRUMENT PERFORMANCE. THE FILED ENGINEER ADDRESSED WELL WASH MODULE AND POST SERVICE THE INSTRUMENT WAS RETURNED TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A FALSE NEGATIVE, REPEATABLE VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HAV IGM RESULT ON A KNOWN POSITIVE ANTI-HAV IGM QUALITY CONTROL FLUID WHEN USING ON THE VITROS ECIQ SYSTEM. BIASED PATIENT SAMPLE RESULTS DID NOT OCCUR. HOWEVER, IF BIASED RESULTS OF THE MAGNITUDE AND DIRECTION WERE OBSERVED ON PATIENT SAMPLES, IT COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. 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 Q IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1