BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    MDR report key: 1181044 · Received September 29, 2008

    Report

    Report Number
    1319681-2008-00289
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 12, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER INVESTIGATED THIS EVENT AND ADJUSTED THE ALIGNMENT OF THE IMMUNO-WASH METERING ARM WHICH RETURNED THE DEVICE TO EXPECTED OPERATING CONDITION. THE INVESTIGATION INTO THIS EVENT CONCLUDES THAT THE ROOT CAUSE WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE OPERATOR OF A VITROS 5, 1 FS CHEMISTRY SYSTEM OBSERVED INSTRUMENT IR WASH ERROR CODES AND BIASED LOW QUALITY CONTROL RESULTS WITH VITROS PHYT SLIDES. THE LABORATORY REPORTED THREE VITROS PHYT PATIENT RESULTS PRIOR TO THE EVENT WHICH REPEATED SUCCESSFULLY. THERE WAS NO ALLEGATION OF PATIENT 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