BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1020247 · Received March 26, 2008

    Report

    Report Number
    1319681-2008-00079
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONCLUDES THAT BIASED RESULTS OBSERVED BY THE USER WERE MOST LIKELY CAUSED BY AN OUT OF SPECIFICATION SETTING OF THE IMMUNOWASH METERING ASSEMBLY ON THE INSTRUMENT. AN OCD SERVICE ENGINEER VISITED THE SITE AND ADJUSTED THE IMMUNOWASH ASSEMBLY. THE ANALYZER HAS BEEN RETURNED TO NORMAL OPERATIONAL STATUS.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED VITROS PHYT RESULTS ON A QUALITY CONTROL FLUID ANALYZED ON A VITROS 5,1 FS ANALYZER. BIASED PATIENT RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THERE WAS NO ALLEGATION OF PATIENT RESULTS AFFECTED OR PATIENT HARM AS A RESULT OF THIS EVENT.

    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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1