BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1904616 · Received November 22, 2010

    Report

    Report Number
    1319681-2010-00256
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 22, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS VANC RESULTS WERE OBTAINED FROM MULTIPLE PATIENT SAMPLES AND QUALITY CONTROL FLUIDS WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE CUSTOMER REPLACED THE PHOTOMETER LAMP TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. FOLLOWING THIS ACTIVITY, ACCEPTABLE VITROS VANC PERFORMANCE WAS OBSERVED. THE ROOT CAUSE OF THIS EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS VANC RESULTS FROM MULTIPLE PATIENT SAMPLES AND QUALITY CONTROL FLUIDS WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER THAN EXPECTED PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. CORRECTED REPORTS WERE ISSUED FOR ALL AFFECTED PATIENT SAMPLE. 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 5,1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1