BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    MDR report key: 1202453 · Received October 8, 2008

    Report

    Report Number
    1319681-2008-00297
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT HAS DETERMINED THAT THE MOST LIKELY ROOT CAUSE WAS ANALYZER RELATED CAUSED BY INCORRECTLY INSTALLED TUBING ON THE IMMUNO WASH MODULE ON THE VITROS 5, 1 FS ANALYZER. THE USER REPLACED THE IMMUNO WASH FLUID TUBING AND RESOLVED THE CONCERN AND RETURNED THE INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED VITROS PHBR AND PHYT RESULTS FROM QUALITY CONTROL FLUIDS ON A VITROS 5, 1 FS ANALYZER. AFTER SEVERAL MAINTENANCE ACTIVITIES, THE ISSUE WAS RESOLVED. THE CUSTOMER STATES THERE WERE NO MISREPORTED RESULTS, AND THERE WAS NO ALLEGATION OF PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO-CLINICAL DIAGNOSTICS, INC. COMPLAINT NUMBER.

    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, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1