BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 1161452 · Received September 12, 2008

    Report

    Report Number
    1319681-2008-00278
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 16, 2008
    Report Date
    August 16, 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

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE CUSTOMER EXPERIENCED IMPRECISE AMMONIA QC RESULTS. AFTER CHANGING THE INCUBATOR EVAPORATION CAPS, ACCEPTABLE RESULTS WERE OBTAINED. THE VITROS 250 INSTRUCTIONS FOR USE INDICATES THAT THE INCUBATOR EVAPORATION CAPS SHOULD BE CLEANED AS NEEDED. THE ROOT CAUSE OF THE EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED IMPRECISE AMMONIA QUALITY CONTROL RESULTS ON THE VITROS 250 ANALYZER. NO PATIENT RESULTS WERE REPORTED. NO PATIENT RESULTS WERE REPORTED IF QUALITY CONTROL RESULTS WERE UNACCEPTABLE. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    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