BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 1710414 · Received June 4, 2010

    Report

    Report Number
    1319681-2010-00111
    Event Type
    Malfunction
    Date Received
    June 4, 2010
    Date of Event
    May 5, 2010
    Report Date
    June 4, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED FROM THE VITROS 5,1 FS CHEMISTRY SYSTEM FOLLOWING A CALIBRATION EVENT. AN OCD FIELD ENGINEER REPLACED THE IR METERING PUMP AND PERFORMED NECESSARY ALIGNMENTS TO RETURN THE INSTRUMENT TO EXPECTED OPERATION. THE ROOT CAUSE OF THIS EVENT IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED PHENOBARBITAL QUALITY CONTROL RESULTS WHILE USING THE VITROS CHEMISTRY PRODUCTS PHBR SLIDE ON A VITROS 5,1 FS CHEMISTRY SYSTEM. PATIENT SAMPLES WERE NOT AFFECTED. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. 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