BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 23076810 · Received September 17, 2025

    Report

    Report Number
    3007111389-2025-00103
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    10758750002504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS TROPI ES LOT 6011 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. REPORTED QC FLUID PERFORMANCE INDICATES A VITROS TROPI ES LOT 6011 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS PRODUCT TROPI ES, LOT 6011. AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT, AS NO WITHIN-RUN DIAGNOSTIC PRECISION TESTING WAS CONDUCTED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WHEN REQUESTED. ADDITIONALLY, FAILURE TO PERFORM MAINTENANCE ACTIVITIES WHEN SIGNALED BY THE INSTRUMENT CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT AS THE VITROS TROPI ES RESULT OF 10.3 NG/ML WAS POSED WITH AN EM (EXPIRED MAINTENANCE) TEST CODE. FURTHERMORE, PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE TO DETERMINE WHETHER THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURE'S RECOMMENDATION FOR SAMPLE CENTRIFUGATION AND CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS LIKELY PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. TURBIDITY OR HEMOLYSIS IN THE PATIENT SAMPLE DID NOT LIKELY CONTRIBUTE TO THE EVENT AS THE CUSTOMER INDICATED THE PATIENT SAMPLE DID NOT APPEAR TURBID OR HEMOLYZED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A NON-REPRODUCIBLE, HIGHER THAN EXPECTED TROPONIN I ES (TROPI ES) RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS TROPI ES LOT 6011 ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PATIENT 1 RESULT OF 10.3 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 NON-REPRODUCIBLE, HIGHER THAN EXPECTED VITROS TROPI ES RESULT WAS REPORTED FROM THE LABORATORY, HOWEVER, A CORRECTED REPORT DOCUMENTING THE VITROS TROPI ES RESULT OF <0.012 NG/ML WAS LATER ISSUED AND NO TREATMENT WAS ALTERED, INITIATED OR STOPPED BASED ON THE REPORTED RESULT. 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) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634659 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC. 6011 10758750002504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown