BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 24381056 · Received February 18, 2026

    Report

    Report Number
    1319681-2026-00008
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 19, 2026
    Report Date
    February 18, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750031610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE CONTROL, LOT: OCR2608, TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS NA+ RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE EXPECTED ESTABLISHED TARGETS FOR THOSE MAS CONTROLS. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED PERFORMANCE ISSUE. DIAGNOSTIC VITROS NA+ WITHIN-RUN PRECISION TESTING WAS NOT COMPLETED DUE TO INSTRUMENT CONDITION CODES. THE CUSTOMER PERFORMED AN AUTO-CENTERING ADJUSTMENT AND ACCEPTABLE VITROS NA+ PRECISION RESULTS WERE OBTAINED FOLLOWING THE ADJUSTMENT. HISTORICAL MAS QUALITY CONTROL RESULTS WERE ALSO UNACCEPTABLE WITHIN THE TIMEFRAME OF THE EVENT, WHICH EXHIBITED WITHIN-LAB IMPRECISION. THIS WITHIN-LAB IMPRECISION WAS LIKELY CAUSED BY THE INSTRUMENT RELATED PERFORMANCE ISSUE RESOLVED BY THE AUTO-CENTERING ADJUSTMENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS THERMOFISHER MAS OMNICORE CONTROL, LOT: OCR2608, TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE VITROS NA+ RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO THE EXPECTED ESTABLISHED TARGET FOR THE MAS CONTROLS. VITROS NA+ SLIDE LOT: 4287-1167-4622 MAS LEVEL 1 NA+ RESULTS OF 146.2, 146.9 AND 136.9 MMOL/L VS. THE EXPECTED RESULT OF 120.33 MMOL/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 NA+ RESULTS THAT MET POTENTIAL HEALTH AND SAFETY CRITERIA WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL SAMPLES. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318014 VITROS XT 7600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown