BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2517159 · Received April 4, 2012

    Report

    Report Number
    1319681-2012-00054
    Event Type
    Malfunction
    Date Received
    April 4, 2012
    Date of Event
    March 5, 2012
    Report Date
    April 4, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULT WAS OBTAINED POST-CALIBRATION OF VITROS PHBR LOT 2537-0058-8452 ON A VITROS 5600 INTEGRATED SYSTEM. THE CUSTOMER RECALIBRATED THE SAME LOT OF VITROS PHBR SLIDES USING ALTERNATE VIALS OF THE CALIBRATOR FLUIDS AS WELL AS A ALTERNATE CARTRIDGE OF PHBR SLIDES TO RESOLVE THE ISSUE. FOLLOWING THIS ACTION, ACCEPTABLE VITROS PHBR QUALITY CONTROL PERFORMANCE WAS OBSERVED. THE ROOT CAUSE OF THIS EVENT IS AN ATYPICAL CALIBRATION OF AN UNKNOWN CAUSE. THE CALIBRATOR FLUIDS, PHBR SLIDE CARTRIDGE IN USE AT THE TIME OF THE EVENT, OR AN ANALYZER RELATED ISSUE, COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTORS OF THE EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS ON A VITROS 5600 INTEGRATED SYSTEM. A RESULT OF 78.7 G/ML WAS OBTAINED FROM THE VITROS TDM PV CONTROL FLUID VERSUS THE EXPECTED VALUE OF 55.94 G/ML. 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 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER DLZ ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1