BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 1162463 · Received September 9, 2008

    Report

    Report Number
    1319681-2008-00265
    Event Type
    Malfunction
    Date Received
    September 9, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 12, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED MAINTENANCE ON THE INSTRUMENT AND HAS RETURNED THE INSTRUMENT TO EXPECTED OPERATION. THE MAINTENANCE INCLUDED THE CLEANING OF EVAPORATION CLIPS IN THE INCUBATOR. THIS CLEANING IS RECOMMENDED TO BE PERFORMED "AS REQUIRED" AS STATED IN THE INSTRUMENTS USER GUIDE. 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 BIASED LOW AND IMPRECISE QUALITY CONTROL RESULTS WITH VITROS AMON SLIDES. THE LABORATORY DID NOT REPORT ANY VITROS AMON PATIENT RESULTS AND THERE WAS NO ALLEGATION OF 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