BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 1910165 · Received November 30, 2010

    Report

    Report Number
    1319681-2010-00260
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDES THAT THE CUSTOMER OBSERVED BIASED VITROS PHYT QUALITY CONTROL RESULTS WHEN USING THEIR VITROS 350 SYSTEM. THE INVESTIGATION DETERMINED THAT THE MOST LIKELY CAUSE OF THE PHS EVENT WAS USER ERROR FOR NOT FOLLOWING THE MANUFACTURER'S INSTRUCTIONS FOR USE FOR THE HANDLING OF THE VITROS IMMUNO-WASH FLUID (IWF). THERE IS NO EVIDENCE THAT THE VITROS 350 ANALYZER OR PHYT REAGENT SLIDES MALFUNCTIONED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS PHYT QUALITY CONTROL RESULTS WHILE USING THE VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. PATIENT SAMPLES WERE NOT TESTED DURING THE INTERVAL THAT THE IMPRECISE QUALITY CONTROL RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. 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