BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I REAGENT PACK

    MDR report key: 24913697 · Received April 17, 2026

    Report

    Report Number
    3007111389-2026-00083
    Event Type
    Malfunction
    Date Received
    April 17, 2026
    Date of Event
    March 25, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    10758750033522
    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 DETERMINED THAT A DISCORDANT, HIGHER THAN EXPECTED TROPONIN I RESULT WAS OBTAINED FROM A PATIENT SAMPLE WHEN TESTED USING THE VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 0030 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE VITROS TROPONIN I ES (TROPI ES) METHOD RESULT FOR THE SAME SAMPLE. AN ASSIGNABLE CAUSE FOR THE DISCORDANT HIGHER THAN EXPECTED PATIENT SAMPLE RESULT COULD NOT BE DETERMINED. BASED ON THE ORTHO FIELD APPLICATION SPECIALIST (FAS)S ACCEPTABLE QUALITY CONTROL (QC) AND CALIBRATOR FLUID RESULTS, A VITROS HSTNI LOT 0030 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. BASED ON THE ORTHO FASS ACCEPTABLE WITHIN RUN PRECISION STUDY, AN INSTRUMENT RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS IDENTIFIED AN INCREASE IN HSTNI COMPLAINTS. VITROS HSTNI IS NEW ASSAY TO MARKET AND LOT 0030 IS ONLY ONE OF THREE LOTS RELEASED. THEREFORE, A POTENTIAL QUALITY ISSUE (PQI) RECORD (B)(4) HAS BEEN CREATED TO INVESTIGATE THIS ISSUE FURTHER. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS UNKNOWN IF THE CUSTOMER AND/OR ORTHO FAS WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURES RECOMMENDATION FOR SAMPLE CENTRIFUGATION. AS A RESULT, IMPROPER PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CONTRIBUTED TO THE EVENT. AT THE TIME OF THE INITIAL SAMPLE COLLECTION, PATIENT (B)(6) HAD BEEN DIAGNOSED WITH COPD AND SHORTNESS OF BREATH. NO MEDICATIONS THAT THE PATIENT MAY HAVE BEEN TAKING WERE PROVIDED. THE POTENTIAL IMPACT OF PATIENT-SPECIFIC FACTORS, SUCH AS MEDICATION USE OR CLINICAL STATUS CANNOT BE ASSESSED AS PART OF THIS INVESTIGATION. CONSEQUENTLY, IT IS POSSIBLE THAT UNKNOWN PATIENT RELATED FACTORS MAY HAVE CONTRIBUTED TO THE HIGHER-THAN-EXPECTED VITROS HSTNI PATIENT SAMPLE RESULTS. PER A MEDICAL CONSULTATION WITH AN ORTHO MEDICAL SAFETY OFFICER (MSO) ON (B)(6) 2025: FOR PATIENT (B)(6): IN THE UNUSUAL EVENT THAT THIS ISSUE WERE TO RECUR, THERE IS A LOW POSSIBILITY THAT A FALSELY REDUCED TROPONIN I ES RESULT OF THIS MAGNITUDE COULD CONTRIBUTE TO DELAYED RECOGNITION OF MYOCARDIAL INJURY, PARTICULARLY IF SERIAL TESTING OR COMPLEMENTARY CLINICAL ASSESSMENT WERE NOT APPROPRIATELY PERFORMED. SUCH A DELAY COULD POTENTIALLY RESULT IN DELAYED DIAGNOSIS OF MYOCARDIAL POTENTIALLY LEADING TO WORSENING CLINICAL OUTCOMES WITH SERIOUS OR LONG-TERM SEQUELAE. SERIOUS PATIENT INJURY, WHILE REMOTE, IS POSSIBLE. THEREFORE, THIS RESULT IS REPORTABLE. ADDITIONALLY, IT IS POSSIBLE THAT AN INTERFERENT AFFECTING THE VITROS HSTNI METHOD BUT NOT THE VITROS TROPI ES METHOD CONTRIBUTED TO THE HIGHER THAN EXPECTED PATIENT SAMPLE RESULT. THE VITROS HSTNI INSTRUCTIONS FOR USE (IFU) STATES: "DEXTRAN AT THERAPEUTIC DOSES SIGNIFICANTLY INTERFERES WITH THIS TEST. HETEROPHILE AS WELL AS HUMAN ANTI-ANIMAL ANTIBODIES (MOST COMMON HUMAN ANTI-MOUSE ANTIBODIES OR HAMA) IN SERUM OR PLASMA OF CERTAIN INDIVIDUALS ARE KNOWN TO CAUSE INTERFERENCE WITH IMMUNOASSAYS." HOWEVER, THE CUSTOMER DID NOT PERFORM ANY INTERFERENCE TESTING ON THE PATIENT SAMPLES. CONSEQUENTLY, AN INTERFERENT THAT IMPACTS THE VITROS HSTNI METHOD BUT NOT THE VITROS TROPI ES METHOD CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENTS. THE DATA PROVIDED WERE GENERATED AS PART OF A CORRELATION STUDY CONDUCTED TO SUPPORT THE LABORATORY INTRODUCTION OF A NEW ASSAY, VITROS HIGH SENSITIVITY TROPONIN I (HSTNI). RESULTS OBTAINED USING THE VITROS HSTNI ASSAY WERE COMPARED TO RESULTS GENERATED BY THE CURRENTLY IN USE VITROS TROPONIN I ES ASSAY AS PART OF ROUTINE VERIFICATION ACTIVITIES. AS VITROS HSTNI IS A HIGH SENSITIVE ASSAY, IT IS DESIGNED TO DETECT LOWER CONCENTRATIONS OF TROPONIN I THAN THE EXISTING ASSAY AND POTENTIALLY ENABLING EARLIER DETECTION OF CARDIAC INJURY. THEREFORE, IT IS POSSIBLE THAT RESULTS BETWEEN THE VITROS HSTNI AND TROPI ES ASSAYS WILL NOT ALWAYS BE 100% CONCORDANT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A DISCORDANT, HIGHER THAN EXPECTED TROPONIN I RESULT WAS OBTAINED FROM A PATIENT SAMPLE WHEN TESTED USING THE VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 0030 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO THE VITROS TROPONIN I ES (TROPI ES) METHOD RESULT FOR THE SAME SAMPLE. PATIENT F16 VITROS HSTNI RESULT OF 126.2 NG/L (>9 NG/L, UPPER REFERENCE LIMIT (URL) CUTOFF) VS. EXPECTED NEGATIVE RESULT OF < 0.012 NG/L (< 0.034 NG/L, VITROS TROPI ES URL CUTOFF). THE HIGHER THAN EXPECTED VITROS HSTNI RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE HAVE BEEN NO 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
    593581 VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC. 0030 10758750033522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown