BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2439755 · Received February 6, 2012

    Report

    Report Number
    1319681-2012-00019
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 9, 2012
    Report Date
    February 6, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED VITROS PHBR QUALITY CONTROL RESULTS WERE OBTAINED POST-CALIBRATION OF VITROS PHBR LOT 2536-0057-0248 ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A REAGENT MALFUNCTION OCCURRED. THE CUSTOMER RECALIBRATED THE SAME LOT OF VITROS PHBR SLIDES USING AN ALTERNATE SET OF CALIBRATOR FLUIDS 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. THE CALIBRATOR FLUIDS IN USE AT THE TIME OF THE EVENT COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED UNEXPECTED VITROS PHBR QUALITY CONTROL RESULTS POST-CALIBRATION OF VITROS PHBR LOT 2536-0057-0248 ON A VITROS 5600 INTEGRATED SYSTEM. RESULTS OF < 3.0, 35.9, AND > 80.0 UG/ML WERE OBTAINED FROM THE VITROS TDM PV CONTROL FLUIDS VERSUS THE EXPECTED VALUES OF 10.72, 26.30, AND 59.95 UG/ML, RESPECTIVELY. 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. (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