BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 3400 INTEGRATED SYSTEM

    MDR report key: 10471371 · Received August 31, 2020

    Report

    Report Number
    1319681-2020-00072
    Event Type
    Malfunction
    Date Received
    August 31, 2020
    Date of Event
    July 29, 2020
    Report Date
    August 31, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DGXN RESULTS WERE OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER AND FROM A NON VITROS BIORAD CONTROL FLUID WHEN USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES LOT 1921-0257-0886 ON A VITROS XT3400 CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE. AS THIS WAS A NEW LOT FOR THE CUSTOMER, HISTORICAL QC DATA WAS NOT AVAILABLE. WHEN ASSESSING THE QC DATA OBTAINED FOLLOWING THE INITIAL CALIBRATION, IT WAS DETERMINED THAT RESULTS WERE IMPRECISE AND ONE INITIAL RESULT BREACHED DGXN PHS CRITERIA. DUE TO THIS RESULT, THE CUSTOMER PROCESSED VITROS DGXN PRECISION TESTS USING TWO DIFFERENT LOTS OF VITROS DGXN, BOTH OF WHICH FAILED. AN ORTHO FIELD ENGINEER THEN PERFORMED SERVICE ACTIONS ON THE VITROS XT3400 CHEMISTRY SYSTEM WHICH INCLUDED VERIFYING THE IMMUNOWASH FLUID (IWF) ZEE MOVEMENTS, VERIFYING THE IWF CARRIER POSITION, PERFORMING IWF ADJUSTMENTS, AND PERFORMING THE IWF PERFORMANCE TEST. FOLLOWING SERVICE ACTIONS, A VITROS DGXN WITHIN RUN PRECISION TEST PRODUCED RESULTS THAT WERE WITHIN ACCEPTABLE GUIDELINES. THIS INDICATES THAT THE PERFORMANCE OF THE VITROS XT3400 CHEMISTRY SYSTEM HAD BEEN RETURNED TO EXPECTATIONS FOLLOWING SERVICE ACTIONS. ALTHOUGH HISTORICAL QUALITY CONTROL RESULTS WERE NOT PROVIDED FOR VITROS DGXN REAGENT LOTS 1921-0257-0886 OR 1921-0257-1708, AN ISSUE RELATED TO THE REAGENT IS NOT A LIKELY CONTRIBUTOR TO THE EVENT AS VITROS DGXN QC RESULTS AND PRECISION RESULTS WERE ACCEPTABLE FOLLOWING SERVICE ACTIONS TO THE VITROS XT3400 CHEMISTRY SYSTEM. IN ADDITION, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH EITHER VITROS DGXN SLIDE LOTS.

    Description of Event or Problem · 1

    AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) LABORATORY SPECIALIST (LS) CONTACTED THE ORTHO GLOBAL TECHNICAL SUPPORT CENTER (TSC) ON BEHALF OF A CUSTOMER TO REPORT IMPRECISE DIGOXIN (DGXN) RESULTS. THE RESULTS WERE OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) AND A NON-VITROS BIORAD CONTROL USING VITROS CHEMISTRY PRODUCTS DGXN SLIDES ON A VITROS XT3400 CHEMISTRY SYSTEM. VITROS TDM III LOT W7852 DGXN RESULTS OF 2.48 AND 2.46 NMOL/L VERSUS AN EXPECTED RESULT OF 3.24 NMOL/L. BIORAD UNASSAYED CHEMISTRY QC RESULT OF 2.50 NMOL/L VERSUS AN EXPECTED RESULT OF 4.14 NMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE VITROS DGXN RESULTS WERE OBTAINED WHEN PROCESSING CONTROL FLUIDS. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION 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
    939750 VITROS XT 3400 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1