BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 19548945 · Received June 17, 2024

    Report

    Report Number
    1319681-2024-00035
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 18, 2024
    Report Date
    June 17, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A LOWER-THAN-EXPECTED RESULT WAS OBTAINED ON THE VITROS PSA ASSAY WHEN THE CUSTOMER WAS PROCESSING NON-VITROS BIORAD QUALITY CONTROL FLUIDS ON THE VITROS XT 7600 INTEGRATED SYSTEM. THE LIKELY ASSIGNABLE CAUSE OF THE EVENT WAS USER ERROR. THE CUSTOMER WAS USING A 70% SOLUTION OF DENATURED ALCOHOL AND NOT USING 70% ISOPROPYL ALCOHOL-IN-WATER AS RECOMMENDED BY ORTHO. AS PER VITROS XT 7600 REFERENCE GUIDE, CLEANING SOLUTIONS WARNING: SODIUM HYPOCHLORITE SOLUTION, BLEACH, AMMONIA, ANY AMMONIA-CONTAINING COMPOUND AND ANY OTHER OXIDIZING AGENTS MAY BE HAZARDOUS, MAY CAUSE ERRONEOUS RESULTS, AND MAY ALSO CORRODE METAL PARTS. ORTHO HAS ADVISED TO DISCONTINUE USING ANY CLEANING SOLUTION FOR THE VITROS OTHER THAN 70% ISOPROPYL ALCOHOL AND DISTILLED WATER. ORTHO ALSO ADVISED TO AVOID USING ANY AMMONIUM-BASED PRODUCTS OR BLEACH ON TABLES WHERE PARTS OR CONSUMABLES THAT GO ONTO A VITROS SYSTEM ARE PLACED. IN ADDITION, THE VITROS XT 7600 INTEGRATED SYSTEMS WERE LOCATED CLOSE TO THE SIEMENS ADVIA 2120 INSTRUMENTS WHICH USES CHLORINE-BASED WASHING SOLUTIONS. THE WASHING OF SAMPLES DURING SAMPLE PROCESSING ON THE SIEMENS SYSTEMS IS NOT CONTAINED AND TAKES PLACE OPEN TO THE ENVIRONMENT. ALTHOUGH NOT DIRECTLY USED ON THE VITROS XT 7600 INTEGRATED SYSTEMS, CHLORINE-BASED CLEANERS ARE KNOWN TO HAVE THE POTENTIAL TO CAUSE ERRONEOUS RESULTS ON THE VITROS SYSTEM. THE CUSTOMER HAS BEEN ADVISED TO MOVE THE VITROS SYSTEMS AND SIEMENS ANALYZERS AWAY FROM EACH OTHER, BUT IT WAS NOT POSSIBLE DUE TO SPACE CONSTRAINTS IN THE LABORATORY. FINALLY, IT WAS DETERMINED THAT THE CUSTOMER WAS REUSING THE FLUID AT THE BOTTOM OF THE UNIVERSAL WASH REAGENT (UWR) THAT WAS CONSIDERED DEAD VOLUME. THE CUSTOMER WAS COMBINING THE DEAD VOLUMES OF MULTIPLE UWR BOTTLES AND LOADING BACK ON THE ANALYZER. AN ORTHO FIELD ENGINEER DETERMINED THAT THE UWR FLUID IN USE AT THE TIME OF THE EVENT WAS CONTAMINATED. ORTHO ADVISED TO STORE UWR IN A COOL ROOM OR AT ROOM TEMPERATURE AND AWAY FROM LIGHT AS IT IS IMPORTANT TO PRESERVE THE CHARACTERISTICS OF THE UWR SOLUTION AND ITS EQUILIBRIUM.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTRE (TSC) TO REPORT A LOWER-THAN-EXPECTED RESULT WAS OBTAINED FROM THE VITROS PSA ASSAY WHEN PROCESSING NON-VITROS BIORAD QUALITY CONTROL FLUIDS ON THE VITROS XT 7600 INTEGRATED SYSTEM. VITROS PSA LOT 1530 ON VITROS XT 76000521: BIORAD LEVEL 3 = 0.27 NG/ML VERSUS BASELINE MEAN 22.19 NG/ML BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED VITROS RESULT WAS OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THE CUSTOMER DEACTIVATED THE MICROWELL SUBSYSTEM UNTIL ORTHO SERVICE WENT ON SITE. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4) REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651387 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown