BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I (HSTNI) REAGENT PACK

    MDR report key: 25176510 · Received May 14, 2026

    Report

    Report Number
    3007111389-2026-00098
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 26, 2026
    Report Date
    May 14, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    10758750033522
    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 DISCORDANT HIGHER THAN EXPECTED VITROS HSTNI RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS HSTNI LOT: 1510 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO A NON-VITROS BECKMAN HIGHLY SENSITIVE TROPONIN I RESULT BELOW THE UPPER REFERENCE INTERVAL (URL). NEITHER THE BECKMAN RESULT OR URL WERE PROVIDED. THE ASSIGNABLE CAUSE OF THE EVENT IS A SAMPLE INTERFERENT THAT AFFECTS THE VITROS HSTNI ASSAYS BUT NOT THE NON-VITROS BECKMAN METHOD. HETEROPHILIC ANTIBODY INTERFERENCE WAS THE CAUSE OF THE EVENT AS THE SAMPLE WAS TREATED WITH HETEROPHILIC BLOCKING TUBE (HBT) AND NON-SPECIFIC ANTIBODY BLOCKING TUBE (NABT), THE VITROS HSTNI RESULTS WERE LOWER FROM THE TREATED SAMPLES. THE HBT MANUFACTURE PACKAGE INSERT STATES IF THE ASSAY RESULT FROM THE HBT TREATED SAMPLE IS DIFFERENT FROM THE ASSAY RESULT FROM THE UNTREATED SAMPLE, THE DIFFERENCE IS DUE TO HETEROPHILIC INTERFERENCE. THE VITROS HSTNI INSTRUCTIONS FOR USE, UNDER OTHER LIMITATIONS STATES HETEROPHILIC ANTIBODIES IN SERUM OR PLASMA SAMPLES MAY CAUSE INTERFERENCE IN 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. THERE WAS NO INDICATION A VITROS INSTRUMENT RELATED PERFORMANCE ISSUE CONTRIBUTED TO THE EVENT, HOWEVER, AS NO DIAGNOSTIC WITHIN-RUN PRECISION TESTING WAS PERFORMED TO ASSESS INSTRUMENT PERFORMANCE, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT. A PERFORMANCE ISSUE WITH VITROS HSTNI REAGENT LOT 1510 DID NOT LIKELY CONTRIBUTE TO THE EVENT AS HISTORICAL QUALITY CONTROL RESULTS WERE ACCEPTABLE, INDICATING VITROS HSTNI REAGENT LOT: 1510 WAS PERFORMING AS INTENDED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC PERFORMANCE ISSUE WITH VITROS HSTNI REAGENT LOT: 1510.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT DISCORDANT HIGHER THAN EXPECTED VITROS HSTNI RESULTS WERE OBTAINED FROM A SINGLE PATIENT SAMPLE WHEN TESTED USING VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I (HSTNI) REAGENT PACK LOT: 1510 ON A VITROS 5600 INTEGRATED SYSTEM. THE RESULTS WERE HIGHER THAN EXPECTED WHEN COMPARED TO A NON-VITROS BECKMAN HIGHLY SENSITIVE TROPONIN I RESULT BELOW THE UPPER REFERENCE INTERVAL (URL). NEITHER THE BECKMAN RESULT OR URL WERE PROVIDED. PATIENT SAMPLE VITROS HSTNI RESULTS OF 550.0, 568.6 AND 513.1 NG/L VERSUS A BECKMAN HIGHLY SENSITIVE TROPONIN I RESULT BELOW THE UPPER REFERENCE INTERVAL (URL). 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 HSTNI RESULTS WERE NOT REPORTED FROM THE LABORATORY AND 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291125 VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I (HSTNI) REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC. 1510 10758750033522

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown