BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I REAGENT PACK

    MDR report key: 24700284 · Received March 26, 2026

    Report

    Report Number
    3007111389-2026-00059
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    January 28, 2026
    Report Date
    March 26, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    10758750032877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT DISCORDANT, HIGHER AND LOWER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED FROM FIVE DIFFERENT PATIENT SAMPLES WHEN TESTED USING THE VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 1441 ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO NON-VITROS BECKMAN METHOD RESULTS FOR THE SAME SAMPLES. AN ASSIGNABLE CAUSE FOR THE DISCORDANT HIGHER AND LOWER THAN EXPECTED PATIENT SAMPLE RESULTS COULD NOT BE DETERMINED. HISTORICAL LEVEL 1 AND LEVEL 3 QC FLUID RESULTS WERE WITHIN EXPECTATIONS; HOWEVER, LEVEL 2 QC RESULTS WERE CONSISTENTLY MORE THAN 2 SD ABOVE THE CUSTOMERS BASELINE MEAN. THEREFORE, A VITROS HSTNI REAGENT ISSUE CANNOT BE CONFIRMED OR RULED OUT AS A CONTRIBUTOR TO THIS EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS HSTNI, LOT 1441. NO PRECISION TESTING WAS PERFORMED ON THE VITROS XT 7600 INTEGRATED SYSTEMS AT THE TIME OF THE EVENTS; THEREFORE, AN INSTRUMENT RELATED ISSUE CANNOT BE FULLY RULED OUT AS A CONTRIBUTOR. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS DETERMINED THAT THE CUSTOMER WAS NOT FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURES RECOMMENDATION FOR SAMPLE CENTRIFUGATION. IT IS POSSIBLE THAT CELLULAR DEBRIS, DUE TO POOR SAMPLE PREPARATION, WAS PRESENT IN THE AFFECTED SAMPLE, HOWEVER, THIS CANNOT BE CONFIRMED. ADDITIONALLY, IT IS POSSIBLE THAT AN INTERFERENT AFFECTING THE VITROS HSTNI METHOD BUT NOT THE NON-VITROS HSTNI METHOD CONTRIBUTED TO THE HIGHER AND LOWER THAN EXPECTED PATIENT SAMPLE RESULTS. THE VITROS HSTNI INSTRUCTIONS FOR USE (IFU) STATES: "HETEROPHILIC ANTIBODIES IN SERUM OR PLASMA SAMPLES MAY CAUSE INTERFERENCE WITH IMMUNOASSAYS. THESE ANTIBODIES MAY BE PRESENT IN BLOOD SAMPLES FROM INDIVIDUALS REGULARLY EXPOSED TO ANIMALS OR WHO HAVE BEEN TREATED WITH ANIMAL SERUM PRODUCTS. RESULTS THAT ARE INCONSISTENT WITH CLINICAL OBSERVATIONS INDICATE THE NEED FOR ADDITIONAL TESTING." 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 BECKMAN METHOD CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE EVENTS.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT, HIGHER AND LOWER THAN EXPECTED TROPONIN I RESULTS WERE OBTAINED FROM FIVE DIFFERENT PATIENT SAMPLES WHEN TESTED USING THE VITROS HIGH SENSITIVITY TROPONIN I (HSTNI) REAGENT LOT 1441 ON TWO DIFFERENT VITROS 5600 INTEGRATED SYSTEMS. THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO NON-VITROS BECKMAN METHOD RESULTS FOR THE SAME SAMPLES. VITROS 5600 INTEGRATED SYSTEM: 56000409 (J1) PATIENT 1, VITROS HSTNI RESULT OF 39.29 NG/L (>11 NG/L, CUTOFF FOR AMI) VS. EXPECTED 9.00 NG/L (<18.00 NG/L, BECKMAN UPPER REFERENCE LIMIT VITROS 5600 INTEGRATED SYSTEM: 56000492 (J2) PATIENT 2, VITROS HSTNI RESULT OF 26.30 NG/L (>11 NG/L, CUTOFF FOR AMI) VS. EXPECTED 11.00 NG/L (<18.00 NG/L, BECKMAN UPPER REFERENCE LIMIT) PATIENT 3, VITROS HSTNI RESULT OF 110.00 NG/L (>11 NG/L, CUTOFF FOR AMI) VS. EXPECTED 7.00 NG/L (<18.00 NG/L, BECKMAN UPPER REFERENCE LIMIT) PATIENT 4, VITROS HSTNI RESULT OF 63.67 NG/L (>11 NG/L, CUTOFF FOR AMI) VS. EXPECTED 8.00 NG/L (<18.00 NG/L, BECKMAN UPPER REFERENCE LIMIT) PATIENT 5, VITROS HSTNI RESULT OF 24.27 NG/L (>11 NG/L, CUTOFF FOR AMI) VS. EXPECTED 10.00 NG/L (<18.00 NG/L, BECKMAN UPPER REFERENCE LIMIT) PATIENT 6, VITROS HSTNI RESULT OF 8.29 NG/L (<11 NG/L, CUTOFF FOR AMI) VS. EXPECTED 32.00 NG/L (>18.00 NG/L, BECKMAN UPPER REFERENCE LIMIT) BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER AND LOWER THAN EXPECTED VITROS HSTNI RESULTS WERE REPORTED BY THE LABORATORY. THE PHYSICIAN QUESTIONED THE ACCURACY OF THE RESULTS AND THEREFORE, THE LABORATORY PERFORMED COMPARISON TESTING USING A NON-VITROS BECKMAN METHOD. IT IS UNKNOWN IF CORRECTED RESULTS WERE REPORTED AND IT IS UNKNOWN IF TREATMENT WAS INITIATED, ALTERED, OR DISCONTINUED BASED ON THE REPORTED RESULTS. THERE WERE NO ALLEGATIONS OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764995 VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC. 1441 10758750032877

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown