BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1952888 · Received January 7, 2011

    Report

    Report Number
    1319681-2011-00007
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT NEGATIVELY BIASED PHYT PATIENT RESULTS WERE OBTAINED FROM THE VITROS 5,1 FS CHEMISTRY SYSTEM. THERE IS NO EVIDENCE TO SHOW THAT PHYT REAGENT SLIDES CONTRIBUTED TO THE EVENT. AN OCD FIELD ENGINEER FOUND THAT REPAIRS TO THE INCUBATOR SUBSYSTEM WERE NECESSARY TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. SYSTEM PERFORMANCE WAS VERIFIED BY PROCESSING QUALITY CONTROL SAMPLES. A DEFINITIVE ROOT CAUSE FOR THE EVENT COULD NOT BE DETERMINED, HOWEVER, THE EVENT WAS MOST LIKELY INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED VITROS PHYT PATIENT RESULTS FOR A SINGLE PATIENT WHILE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. AN AFFECTED PATIENT RESULT WAS REPORTED TO THE CLINICIAN, AND A CORRECTED REPORT WAS ISSUED. THERE WAS NO ALLEGATION OF HARM TO THE PATIENT 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 CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1