BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 24272165 · Received February 5, 2026

    Report

    Report Number
    1319681-2026-00005
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    December 17, 2025
    Report Date
    February 4, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    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 DETERMINED THAT LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED FROM VITROS NBNP2 LOT 0590 WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS LT QUALITY CONTROL (QC) FLUID LOT 1003130 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS AN INSTRUMENT RELATED ISSUE. IT WAS VERIFIED THAT CONDITION CODES RELATED TO THE WELL WASH HEATER FOR LOWER THAN AND HIGHER THAN EXPECTED TEMPERATURES WERE OBTAINED ON THE VITROS XT7600 SYSTEM DURING THE TIME WHEN THE LOW NBNP2 BIORAD QC RESULTS WERE OBTAINED. THE VITROS NBNP2 ASSAY IS HIGHLY SENSITIVE TO WELL WASH TEMPERATURE AND INCUBATOR TEMPERATURE. AN ORTHO FIELD ENGINEER (FE) WENT TO THE CUSTOMER SITE AND PERFORMED THE FOLLOWING ACTIONS: VERIFIED LUMINOMETER SEATING, PERFORMED LUMINOMETER LIFT AND SEPARATE TEST, PERFORMED READ LIFT PIN ADJUSTMENT, -VERIFIED SIGNAL REAGENT (SR) HORIZONTAL AND DISPENSE ADJUSTMENTS, PERFORMED IRS CALIBRATION, REPLACED THE INTAKE FILTER, SR DISPENSE TIPS, AIR FILTER, SR BOTTLE, WELL WASH ASPIRATE FILTER. IN ADDITION, THE FE PERFORMED HEALTH CHECK PER LATEST SERVICE PUBLICATION AND THE MICROWELL PREVENTATIVE MAINTENANCE (PM). ACCEPTABLE RESULTS FOR VITROS NBNP2 WERE OBTAINED FOLLOWING THE SERVICE PERFORMED ACTIONS BY THE ORTHO FE, INDICATING THAT THE LOW QC RESULTS WERE DUE TO AN ISSUE WITH THE VITROS XT7600 SYSTEM. A REVIEW OF THE VITROS NBNP2 LOT 0590 QC PERFORMANCE INDICATED SOME IMPRECISION AROUND THE TIME OF THE EVENT. HOWEVER, FOLLOWING SERVICE ACTIONS ACCEPTABLE PERFORMANCE WAS OBTAINED ON NBNP2 LOT 0590 AS WELL AS A NEW NBNP2 LOT THAT WAS PUT INTO. IT WAS CONCLUDED THAT THE LOW QC RESULTS AND NOTED QC IMPRECISION WAS RELATED TO THE VITROS INSTRUMENT ISSUE. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS NBNP2 LOT 0590.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED NT-PROBNP II (NBNP2) RESULTS WERE OBTAINED FROM VITROS NBNP2 LOT 0590 WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS LT QUALITY CONTROL (QC) FLUID LOT 1003130 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 VITROS NBNP RESULTS OF 143.2, 143.3 PG/ML VS EXPECTED RESULT OF 202.6 PG/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 VITROS NBNP2 RESULTS WERE OBTAINED WHEN PROCESSING NON-VITROS QC FLUID. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 613299.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334808 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown