BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 23244193 · Received October 8, 2025

    Report

    Report Number
    1319681-2025-00046
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 3, 2025
    Report Date
    October 7, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUIDS USING THE IN-USE LOT OF VITROS VANCOMYCIN (VANC) REAGENT TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMER'S ESTABLISHED BASELINE MEANS. THE ASSIGNABLE CAUSE OF THE EVENT IS A TRANSIENT INSTRUMENT-RELATED ISSUE RELATED TO THE COMPRESSOR LOCATED ON VITROS XT 7600 INTEGRATED SYSTEM. THE COMPRESSOR WAS MALFUNCTIONING SO SEVERELY THAT IT CAUSED THE ENTIRE ANALYZER TO SHAKE. THE COMPRESSOR IS LOCATED RIGHT BELOW THE VITROS MICROIMMUNOASSAY (UIA) REAGENT SUPPLY WHERE THE SUPPLY 3 TESTS ARE STORED AND SAMPLED FROM ON THE ANALYZER AND RIGHT ABOVE THE COOLER CONTROL SYSTEM ON THE ANALYZER. THE MALFUNCTIONING OF THE COMPRESSOR COULD HAVE LED TO AN ISSUE PREVENTING PROPER SAMPLING OF THE VITROS VANC REAGENT PACK AND/OR PACK MIXING BY THE UIA REAGENT SUPPLY. AN ORTHO FIELD ENGINEER (FE) ARRIVED ONSITE ON 16 SEPTEMBER 2025, VISUALLY CONFIRMED THE ISSUE AND REPLACED THE SYSTEM COMPRESSOR. AFTER THESE SERVICE ACTIONS WERE PERFORMED, THE CUSTOMER VERBALLY CONFIRMED THAT VITROS MICROTIP ASSAY PERFORMANCE (INCLUDING VITROS VANC) RETURNED TO BASELINE EXPECTATIONS AND THE ANALYZER NO LONGER WAS SHAKING WHEN THE COMPRESSOR WAS ACTIVATED. A REVIEW OF POST-SERVICE QC PERFORMANCE VERIFIED THIS RESOLUTION, AS ALL POST-SERVICE QC RESULTS WERE ACCEPTABLE. HISTORICAL QUALITY CONTROL RESULTS WERE ACCURATE AND PRECISE LEADING UP TO THE DATE OF THE EVENT. THEREFORE, A VITROS VANC REAGENT LOT 2514-56-2940 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. THE LOWER THAN EXPECTED RESULTS WERE ISOLATED TO A SINGLE VITROS VANC LOT 2514-56-2940 REAGENT PACK, HOWEVER, ACCEPTABLE PERFORMANCE USING THIS SAME REAGENT PACK WERE OBSERVED BOTH BEFORE AND AFTER THE EVENT ON (B)(6) 2025, INDICATING THAT A VITROS VANC (LOT 2514-56-2940) REAGENT PACK RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VANC REAGENT LOT 2514-56-2940.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD QUALITY CONTROL (QC) FLUIDS USING THE IN-USE LOT OF VITROS VANCOMYCIN (VANC) REAGENT TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE LOWER THAN EXPECTED WHEN COMPARED TO THE CUSTOMER'S ESTABLISHED BASELINE MEANS. BIORAD LEVEL 3 QC (LOT 85390) RESULT OF < 5.00 AND < 5.00 UG/ML VERSUS THE EXPECTED RESULT OF 29.85 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER-THAN-EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2566546 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown