BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 1932668 · Received December 20, 2010

    Report

    Report Number
    1319681-2010-00281
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 21, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS UNAWARE THAT THE VITROS 350 CHEMISTRY SYSTEM USER GUIDE STATED THAT AMMONIA BASED CLEANERS WERE NOT TO BE USED ON OR NEAR THE ANALYZER. THE INVESTIGATION DETERMINED THAT THE VITROS 350 ANALYZER HAD BEEN CLEANED WITH AN AMMONIA BASED CLEANER. OCD FIELD SERVICE INVESTIGATED, CLEANING THE INCUBATOR AND REPLACING THE INCUBATOR EVAPORATION CAPS. THE SERVICE ACTIVITY RETURNED THE VITROS 350 SYSTEM TO EXPECTED OPERATION. THE ROOT CAUSE OF THE POSITIVELY BIASED AMON RESULTS IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED POSITIVELY BIASED QUALITY CONTROL RESULTS USING VITROS AMON SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PATIENT RESULTS WERE AFFECTED AND THERE WERE NO ALLEGATIONS OF HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1