BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 1872984 · Received October 18, 2010

    Report

    Report Number
    1319809-2010-00016
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 19, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHYT RESULTS OCCURRED ON ONE PATIENT SAMPLE PROCESSED ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, AN UNKNOWN INTERFERENT WITHIN THE SAMPLE COULD NOT BE RULED OUT. NO ANALYZER MALFUNCTION WAS IDENTIFIED. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THIS CUSTOMER OBSERVED IMPRECISE, LOW BIASED PHENYTOIN RESULTS ON ONE PATIENT SAMPLE USING VITROS CHEMISTRY PRODUCTS PHYT SLIDES ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED PATIENT RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION SHOULD THEY OCCUR ON PATIENT SAMPLES. THE RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2649-0115-4692

    Patients

    Seq Age Sex Outcome Treatment
    1