BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1120007 · Received August 14, 2008

    Report

    Report Number
    1319681-2008-00242
    Event Type
    Malfunction
    Date Received
    August 14, 2008
    Date of Event
    July 20, 2008
    Report Date
    July 20, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN OCD FIELD ENGINEER PERFORMED MAINTENANCE AND REPAIRS ON THE INSTRUMENT, 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

    A CUSTOMER OBSERVED IMPRECISE VITROS AMON RESULTS FROM QUALITY CONTROL FLUIDS ON A VITROS 5,1 FS ANALYZER. THE CUSTOMER STATES THERE WERE NO MISREPORTED RESULTS AND 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