BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 1514201 · Received October 21, 2009

    Report

    Report Number
    1319681-2009-00333
    Event Type
    Malfunction
    Date Received
    October 21, 2009
    Date of Event
    September 20, 2009
    Report Date
    September 22, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JIF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OCD FIELD SERVICE INVESTIGATED. THE INCUBATOR WAS CLEANED AND THE INCUBATOR EVAPORATION CAPS WERE REPLACED, RETURNING THE VITROS 350 TO EXPECTED OPERATION. THE ROOT CAUSE OF THIS EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSELY ELEVATED, NON-REPRODUCIBLE RESULTS ON TWO PT SAMPLES PROCESSED USING VITROS AMON SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE FALSELY ELEVATED RESULTS WERE NOT REPORTED OUTSIDE THE LAB. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY SYSTEM JIF ORTHO-CLINICAL DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1