BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 1200079 · Received October 15, 2008

    Report

    Report Number
    1319681-2008-00309
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER PERFORMED MAINTENANCE ON THE INSTRUMENT TO REPLACE THE IMMUNOWASH FLUID METERING PUMP AND HAS RETURNED THE INSTRUMENT TO EXPECTED OPERATION. THE INVESTIGATION INTO THIS EVENT CONCLUDES THAT THE ROOT CAUSE WAS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE OPERATOR OF A VITROS 250 CHEMISTRY SYSTEM OBSERVED NEGATIVELY BIASED QUALITY CONTROL RESULTS WITH VITROS PHYT SLIDES ASSAYED ON A VITROS 250 CHEMISTRY SYSTEM. THE CUSTOMER HAS OBSERVED ERROR CODES FOR THE IMMUNOWASH METERING SYSTEM AND IMPRECISE QC RESULTS FOR PHYT INTERMITTENTLY PRIOR TO THIS EVENT. THE LABORATORY HAS NOT RECEIVED ANY REPORTS OF INACCURATE VITROS PHYT PATIENT RESULTS DURING THE TIME OF THIS EVENT AND THERE WAS NO ALLEGATION OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 250 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1