BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 24799596 · Received April 7, 2026

    Report

    Report Number
    1319681-2026-00021
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 7, 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 HAS DETERMINED THAT REPRODUCIBLE, HIGHER-THAN-EXPECTED TROPONIN ES RESULTS WERE OBTAINED FROM FOUR DIFFERENT PATIENT SAMPLES WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES (TROPI ES) REAGENT PACK, LOT: 6390 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT RESULTS OBTAINED FROM THE SAME PATIENT SAMPLES ON A SECOND VITROS XT 7600 INTEGRATED SYSTEM. ADDITIONALLY, HIGHER THAN EXPECTED VITROS TROPI ES LOT: 6390 RESULTS WERE OBTAINED DURING A PRECISION TEST USING SPECIALTY DILUENT FLUID (KNOWN TROPONIN FREE SAMPLE). THE ASSIGNABLE CAUSE OF THE HIGHER-THAN-EXPECTED RESULTS WAS LIKELY AN INSTRUMENT ISSUE RELATED TO INCUBATOR CONTAMINATION. THE RESULTS OF TWO VITROS TROPI ES WITHIN RUN PRECISION TESTS PERFORMED ON THE VITROS INSTRUMENT BY THE CUSTOMER WERE NOT WITHIN ORTHO ACCEPTABLE GUIDELINES. IT WAS ESTABLISHED THAT THE CUSTOMER WAS NOT PERFORMING ROUTINE CLEANING AND MAINTENANCE ON THE VITROS XT 7600 INTEGRATED SYSTEM IN ACCORDANCE WITH ORTHO GUIDELINES. AN ORTHO SENIOR FIELD ENGINEER (SFE) VISITED THE CUSTOMER SITE AND PERFORMED SERVICE AND MAINTENANCE ACTIONS, INCLUDING A DEEP CLEANING OF THE MICROWELL INCUBATOR, REPLACED ALL WET SIGNAL REAGENT COMPONENTS. FOLLOWING THESE ACTIONS, THE ORTHO SFE CONDUCTED A WITHIN-RUN VITROS TROPI ES PRECISION TEST ON THE INSTRUMENT, WHICH YIELDED ACCEPTABLE RESULTS, INDICATING THAT THE SERVICE ACTIONS RESTORED THE VITROS ANALYZER TO EXPECTED PERFORMANCE.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT REPRODUCIBLE, HIGHER-THAN-EXPECTED TROPONIN ES RESULTS OBTAINED FROM FOUR DIFFERENT PATIENT SAMPLES WHEN USING VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES (TROPI ES) REAGENT PACK, LOT: 6390 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT RESULTS OBTAINED FROM THE SAME PATIENT SAMPLES ON A SECOND VITROS XT 7600 INTEGRATED SYSTEM. ADDITIONALLY, HIGHER THAN EXPECTED VITROS TROPI ES LOT: 6390 RESULTS WERE OBTAINED DURING A PRECISION TEST USING SPECIALTY DILUENT FLUID (KNOWN TROPONIN FREE SAMPLE). VITROS XT 7600 INTEGRATED SYSTEM: S/N: (B)(6) (J1) PATIENT 1, VITROS TROPI ES RESULT OF 0.069 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 2, VITROS TROPI ES RESULTS OF 0.087, 0.072, AND 0.075 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 3, VITROS TROPI ES RESULTS OF 0.078 AND 0.057 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML PATIENT 4, VITROS TROPI ES RESULT OF 0.073 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML VITROS TROPI ES PRECISION RESULTS OF 0.061, 0.059 AND 0.067 NG/ML VERSUS THE EXPECTED RESULT OF <0.012 NG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE REPRODUCIBLE HIGHER-THAN-EXPECTED VITROS TROPI ES RESULTS WERE NOT REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF HARM AS A RESULT OF THE 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
    241778 VITROS XT 7600 INTEGRATED SYSTEM CLINICAL CHEMISTRY JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750031610

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown