BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 6598425 · Received May 30, 2017

    Report

    Report Number
    1319681-2017-00042
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    May 1, 2017
    Report Date
    May 30, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DGXN QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS DGXN RESULTS WAS INSTRUMENT RELATED. THE ISSUE WAS ISOLATED TO THE AFFECTED VITROS 5600 SYSTEM; AN ALTERNATE VITROS 350 SYSTEM ON SITE WAS NOT AFFECTED. IN ADDITION, THREE DIFFERENT CALIBRATION EVENTS ON THE VITROS 5600 SYSTEM WERE UNSUCCESSFUL. AN ORTHO FE WENT ON SITE AND PERFORMED SERVICE ACTIONS TO THE IMMUNO WASH FLUID (IWF) SUBSYSTEM OF THE VITROS 5600 SYSTEM, WHICH INCLUDED REPLACING THE IMMUNO-RATE WASH CAM AND THE SIDE LOAD LEAF SPRING, AND THEN PERFORMING ALL NECESSARY IWF AND WASH SHUTTLE ADJUSTMENTS. VITROS DGXN SLIDE LOT 1913-0242-9236 WAS SUCCESSFULLY CALIBRATED AFTER SERVICE ACTIONS WERE COMPLETED AND POST CALIBRATION VITROS TDM PV RESULTS WERE WITHIN THE VITROS ROM.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS DGXN QUALITY CONTROL RESULTS OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 3 LOT 46570 DGXN RESULTS OF 1.49 AND 1.02 NG/ML VS. AN EXPECTED RESULT OF 2.263 NG/ML. VITROS TDM PV III LOT A4560 DGXN RESULTS OF 1.78, 1.89, 1.98, 1.91, 1.95, 1.90, 1.88, AND 1.97 NG/ML VS. AN EXPECTED RESULT OF 2.58 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE CUSTOMER STATED THAT DURING THE TIMEFRAME OF THE EVENT, NO VITROS DGXN PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 1902510/IVD404257.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380922 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1