BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 24272105 · Received February 5, 2026

    Report

    Report Number
    1319681-2026-00004
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    December 27, 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
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED NT-PROBNP II (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS LT QUALITY CONTROL (QC) FLUID LOT 1003110 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS AN INSTRUMENT RELATED ISSUE. REVIEW OF THE INSTRUMENTS MECHANICAL PERFORMANCE IDENTIFIED MICROWELL INCUBATOR SHUTTLE-RELATED ERROR CODES. ADDITIONALLY, THE LUMINOMETER IRS SIGNAL DROPPED TO ZERO ON TWO OCCASIONS WITHIN THE TWO-WEEK REVIEW PERIOD. AS PART OF TROUBLESHOOTING, THE CUSTOMER PERFORMED WEEKLY MAINTENANCE ON THE MICROWELL SUBSYSTEM. IN ADDITION, THEY CLEANED THE FIBER OPTIC BUNDLE (FOB) AND COMPLETED AN IRS CALIBRATION PER AS REQUIRED MAINTENANCE. THE BIORAD QC RESULTS WERE ACCEPTABLE FOLLOWING COMPLETION OF THESE WEEKLY AND AS REQUIRED MAINTENANCE ACTIVITIES. A REVIEW OF QC PERFORMANCE PRIOR TO THE REPORTED EVENT CONFIRMED THAT THE VITROS NT-PROBNP II ASSAY WAS PERFORMING AS EXPECTED WHEN COMPARED TO THE LABORATORIES QC MEAN AND RANGE. A SUBSEQUENT REVIEW OF NT-PROBNP II QC RESULTS FOLLOWING MAINTENANCE ACTIVITIES CONFIRMED THAT THE NON-VITROS BIO-RAD LIQUICHEK CARDIAC MARKER PLUS LT QC RESULT WERE PERFORMING AS EXPECTED. BASED ON THIS DATA, A REAGENT-RELATED ISSUE WAS RULED OUT AS A CONTRIBUTOR TO THE EVENT. IN ADDITION, CONTINUAL TRACK AND COMPLAINT TRENDING HAS NOT IDENTIFIED ANY SIGNALS INDICATING A POTENTIAL SYSTEMATIC ISSUE ASSOCIATED WITH VITROS NT-PROBNP II REAGENT LOT 2140.

    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 (NTBNP II) RESULTS WERE OBTAINED WHEN PROCESSING A NON-VITROS BIORAD LIQUICHEK CARDIAC MARKER PLUS LT QUALITY CONTROL (QC) FLUID LOT 1003110 ON A VITROS XT 7600 INTEGRATED SYSTEM. BIORAD LEVEL 2 RESULTS OF 10.93, 11.07, 11.30 AND 12.87 PMOL/L VS EXPECTED RESULT OF 17.3 PMOL/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 LOWER THAN EXPECTED VITROS NTBNP II 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582863 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown