BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK

    MDR report key: 23848817 · Received December 19, 2025

    Report

    Report Number
    3007111389-2025-00139
    Event Type
    Malfunction
    Date Received
    December 19, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 18, 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 HAS DETERMINED THAT A HIGHER-THAN-EXPECTED TROPONIN ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 6070 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A VITROS HS TROPONIN I (HSTNI) RESULT AND A NON-VITROS ROCHE TROPONIN T RESULT OBTAINED FROM THE SAME PATIENT SAMPLE. THE ASSIGNABLE CAUSE OF THE NON-REPRODUCIBLE HIGHER THAN EXPECTED PATIENT SAMPLE RESULT COULD NOT BE DETERMINED. BASED ON HISTORICAL QC FLUID RESULTS, A VITROS TROPI ES LOT 6070 PERFORMANCE ISSUE IS NOT LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, THE CUSTOMER DOES NOT PROCESS A CONTROL FLUID WITH A TROPONIN I CONCENTRATION AT OR BELOW THE URL. THEREFORE, THE PERFORMANCE OF THE VITROS TROPI ES REAGENT LOT 6011 AT OR BELOW THE URL CONCENTRATION OF 0.034 NG/ML CANNOT BE DETERMINED, AND A REAGENT ISSUE CANNOT BE ENTIRELY RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENT. THE CUSTOMER DECLINED TO PERFORM WITHIN-RUN PRECISION TESTING; THEREFORE, INSTRUMENT PERFORMANCE AT THE TIME OF THE EVENT COULD NOT BE VERIFIED. HOWEVER, THERE WAS NO EVIDENCE INDICATING AN INSTRUMENT RELATED ISSUE. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR AS THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURERS RECOMMENDED CENTRIFUGATION PROTOCOL. IMPROPER PRE-ANALYTICAL SAMPLE HANDLING COULD HAVE CONTRIBUTED TO THE EVENT. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, ALTHOUGH THIS COULD NOT BE CONFIRMED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD INDICATE A POTENTIAL SYSTEMATIC ISSUE WITH VITROS TROPI ES REAGENT LOT 6070.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER-THAN-EXPECTED TROPONIN ES RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE USING VITROS TROPONIN I ES (TROPI ES) REAGENT LOT 6070 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A VITROS HS TROPONIN I (HSTNI) RESULT AND A NON-VITROS ROCHE TROPONIN T RESULT OBTAINED FROM THE SAME PATIENT SAMPLE. VITROS TROPI ES PATIENT RESULT OF 0.121 NG/ML (UG/L) (> AMI CUTOFF) VERSUS THE EXPECTED RESULTS < AMI CUTOFF (ROCHE RESULT NEGATIVE, VITROS HSTNI RESULT <1.5 NG/L) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER-THAN-EXPECTED VITROS TROPI ES RESULT OF 0.121 UG/L WAS REPORTED FROM THE LABORATORY. THE ORTHO FAS STATED THAT THE SAMPLE WAS NOT REPEATED USING VITROS TROPI ES, AND THAT THE SAMPLE WAS ONLY REPEATED USING VITROS HSTNI. HOWEVER, A CORRECTED REPORT WAS LATER ISSUED FOR A RESULT OF <0.012 NG/ML (UG/L) (LESS THAN THE VITROS TROPI ES MEASURING RANGE). NO TREATMENT WAS INITIATED, ALTERED, 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
    251762 VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC. 6070 10758750002504

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown