BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM-REMANUFACTURED

    MDR report key: 1151017 · Received August 28, 2008

    Report

    Report Number
    1319681-2008-00260
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER PERFORMED MAINTENANCE ON THE INSTRUMENT TO REPLACE THE SLIDE INCUBATOR CAPS, AND CLEANED THE INCUBATOR 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 QUALITY CONTROL RESULTS HIGH, OUTSIDE OF EXPECTED RANGE, WITH VITROS AMON SLIDES. NO PT RESULTS WERE REPORTED DURING THIS EVENT AND THE LAB DID NOT REPORT ANY ALLEGATION OF PT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC COMPLAINT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1