BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1222836 · Received November 6, 2008

    Report

    Report Number
    1319681-2008-00336
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT HAS DETERMINED THAT THE ROOT CAUSE WAS AN IMMUNO WASH METERING MODULE THAT WAS OUT OF ADJUSTMENT ON THE VITROS 5,1 FS ANALYZER. AN OCD ENGINEER WAS DISPATCHED TO THE USER'S SITE AND PERFORMED NECESSARY REPAIRS AND ADJUSTMENTS RETURNING THE INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED ANALYZER ERROR CODES AND IMPRECISE VITROS PHYT RESULTS FROM QUALITY CONTROL FLUIDS ON A VITROS 5,1 FS ANALYZER. THE CUSTOMER STATES THERE WAS NO ALLEGATION OF PT HARM AS A RESULT OF THIS EVENT.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1