BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1556833 · Received November 19, 2009

    Report

    Report Number
    1319681-2009-00369
    Event Type
    Injury
    Date Received
    November 19, 2009
    Date of Event
    October 16, 2009
    Report Date
    October 21, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT THE CUSTOMER HAD OBSERVED BOTH POSITIVELY AND NEGATIVELY BIASED QUALITY CONTROL RESULTS FOR MULTIPLE MICROWELL ASSAYS ON THE VITROS 5600 SYSTEM. OCD FIELD SERVICE INVESTIGATED AND RE-CALIBRATED THE MICROWELL SUBSYSTEM LUMINOMETER. FOLLOWING THE SERVICE ACTIVITY, ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED FOR ALL MICROWELL ASSAYS. THE MOST LIKELY ROOT CAUSE OF THE BIASED VITROS CKMB, MYOGLOBIN, AND TOTAL BHCG II QUALITY CONTROL RESULTS IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED LOWER THAN EXPECTED RESULTS FOR QUALITY CONTROL SAMPLES PROCESSED USING VITROS CKMB, MYOGLOBIN, AND TOTAL BHCG II REAGENTS ON A VITROS 5600 INTEGRATED SYSTEM IN 2009. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED, IF THEY WERE TO OCCUR ON PT SAMPLES, MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PT RESULTS WERE NOT REPORTED WHILE QUALITY CONTROL WAS UNACCEPTABLE. 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 5600 INTEGRATED SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1