BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 2523914 · Received April 9, 2012

    Report

    Report Number
    1319681-2012-00060
    Event Type
    Malfunction
    Date Received
    April 9, 2012
    Date of Event
    March 7, 2012
    Report Date
    April 9, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS OBTAINED FROM MULTIPLE CONTROL FLUIDS AFTER TWO DIFFERENT CALIBRATION EVENTS OF VITROS PHBR LOT 2537-0058-8565 ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE ROOT CAUSE OF THIS EVENT IS ANALYZER RELATED. ACCEPTABLE VITROS PHBR QUALITY CONTROL PERFORMANCE WAS OBSERVED WITH AN ALTERNATE VITROS 5,1 FS CHEMISTRY SYSTEM ON SITE. AN OCD FE PERFORMED SERVICE ACTIONS TO THE IWR AND INCUBATOR SUBSYSTEMS OF THE 5,1 FS ANALYZER. AFTER THE SERVICE ACTIONS WERE PERFORMED, PHBR PERFORMANCE IMPROVED, HOWEVER SOME CONTROL RESULTS REMAINED OUTSIDE OF THE ESTABLISHED RANGES FOR PHBR. THE CUSTOMER DID NOT WISH TO CONTINUE THE INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS OBTAINED FROM MULTIPLE CONTROL FLUIDS AFTER TWO DIFFERENT CALIBRATION EVENTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. NON-VITROS LEVEL 1 CONTROL: 18.1, 17.2, 19.6, 17.8 UG/ML VS. THE CUSTOMER MEAN OF 14.0. NON-VITROS LEVEL 2 CONTROL: 54.5, 57.4 UG/ML VS. THE CUSTOMER MEAN OF 45.0. TDM PERFORMANCE VERIFIER I: 13.1, 14.2, 14.1, 13.4, 13.6, 14.0, 13.9, 14.1, 13.9, 13.5, 14.0, 13.8, 13.8, 13.8 UG/ML VS. THE MIDPOINT OF THE RANGE OF MEANS OF 9.95. TDM PERFORMANCE VERIFIER III: >80.0, >80.0, 71.0, 69.5, 68.1, 68.5 UG/ML VS. THE MIDPOINT OF THE RANGE OF MEANS OF 55.94. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. PATIENT SAMPLES WERE NOT TESTED FOR VITROS PHBR WHILE QUALITY CONTROL RESULTS WERE OUTSIDE OF EXPECTED RANGES. 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 CHEMISTRY ANALYZER DLZ ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1