BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 1569647 · Received December 2, 2009

    Report

    Report Number
    1319681-2009-00379
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    November 2, 2009
    Report Date
    November 3, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT VITROS PHYT OR THE VITROS 250 DID NOT OPERATE AS INTENDED. THE CUSTOMER HAD MULTIPLE LOTS OF IMMUNOWASH FLUID (IWF) ON SITE AND INDICATED THAT THEY FOLLOW THE MFR'S RECOMMENDATION FOR CALIBRATION OF EACH IMMUNOWASH FLUID (IWF) LOT. FURTHER INVESTIGATION OF THE IWF LOT IN USE AT THE TIME COULD NOT BE PERFORMED DUE TO INVENTORY ISSUES. THE ROOT CAUSE OF THE NEGATIVELY BIASED QUALITY CONTROL FLUID RESULTS COULD NOT BE DETERMINED, HOWEVER, THE IMMUNOWASH FLUID (IWF) LOT IN USE AT THE TIME COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED NEGATIVELY BIASED QUALITY CONTROL RESULTS USING VITROS PHYT SLIDES ON A VITROS 250 CHEMISTRY SYSTEM ON (B)(6) AND (B)(6)2009. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. PT SAMPLES WERE NOT PROCESSED WHILE QUALITY CONTROL WAS UNACCEPTABLE. 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 250 CHEMISTRY SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1