BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1222833 · Received November 6, 2008

    Report

    Report Number
    1319681-2008-00333
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 9, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    OCD FIELD SERVICE INVESTIGATED AND MADE NECESSARY REPAIRS TO THE INCUBATOR SUBSYSTEM, RETURNING THE VITROS ECIQ TO EXPECTED OPERATION. THE ROOT CAUSE OF THE NON-REPRODUCIBLE, FALSELY ELEVATED TROP I ES RESULT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED NON-REPRODUCIBLE, FALSELY ELEVATED VITROS TROP I ES RESULTS ON A SINGLE PT SAMPLE ON THE VITROS ECIQ. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PT RESULTS WERE QUESTIONED AND THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNOASSAY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1