BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1222834 · Received November 6, 2008

    Report

    Report Number
    1319681-2008-00334
    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
    LA, 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 ECI TO EXPECTED OPERATION. THE ROOT CAUSE OF THE IMPRECISE TROP I ES RESULTS IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED IMPRECISE QUALITY CONTROL RESULTS USING VITROS TROP I ES ON A VITROS ECI. DURING TROUBLESHOOTING, HIGH OUTLIERS WERE OBSERVED DURING TROP I ES PRECISION TESTING. 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 ECI IMMUNODIAGNOSTIC SYSTEM IMMUNOASSAY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1