BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1870203 · Received October 15, 2010

    Report

    Report Number
    1319681-2010-00224
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 16, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE VITROS PHYT RESULTS OCCURRED ON CONTROL FLUIDS PROCESSED ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. THE DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, A REAGENT OR AN ANALYZER ISSUE COULD NOT BE RULED OUT. AN OCD FIELD ENGINEER HAS RETURNED THE SYSTEM TO EXPECTED OPERATION. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THIS CUSTOMER OBSERVED IMPRECISE, NEGATIVELY BIASED PHENYTOIN RESULTS ON CONTROL FLUIDS 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. 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 5,1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1