BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 1936287 · Received December 22, 2010

    Report

    Report Number
    1319681-2010-00287
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A NEGATIVELY BIASED PHYT QUALITY CONTROL RESULT WAS OBTAINED FROM THE VITROS 250 CHEMISTRY SYSTEM. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, A NON-OPTIMAL CALIBRATION OR AN IMMUNO WASH FLUID RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING FACTORS TO THE EVENT. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST THAT THE RESULT IN QUESTION WAS CAUSED BY A PHYT SLIDE REAGENT MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A NEGATIVELY BIASED VITROS PHYT QUALITY CONTROL RESULT WHILE USING THE VITROS 250 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THE EVENT WERE TO RECUR WITH PATIENT SAMPLES. 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 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1