BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I REAGENT PACK

    MDR report key: 25072417 · Received May 4, 2026

    Report

    Report Number
    3007111389-2026-00091
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 5, 2026
    Report Date
    May 4, 2026
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A DISCORDANT, HIGHER THAN EXPECTED HSTNI RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS HSTNI LOT 1510 ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS BIOMERIEUX TROPONIN I RESULT FOR THE SAME PATIENT SAMPLE. A DEFINITIVE CAUSE OF THE EVENT WAS NOT ESTABLISHED. REPORTED QC FLUID PERFORMANCE INDICATES A VITROS HSTNI LOT 1510 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. HOWEVER, THE CUSTOMER DOES NOT PROCESS A CONTROL FLUID WITH A TROPONIN I CONCENTRATION AT, OR BELOW THE 99TH PERCENTILE. THEREFORE, THE PERFORMANCE OF THE VITROS HSTNI LOT 1510 AT, OR BELOW THE 99TH PERCENTILE CONCENTRATION OF 11 NG/L CANNOT BE DETERMINED AND A REAGENT ISSUE COULD NOT BE ENTIRELY RULED OUT AS CONTRIBUTING TO THE EVENT. NO PRECISION TESTING WAS PERFORMED ON THE INSTRUMENT, SO IT WAS NOT POSSIBLE TO VERIFY THE PERFORMANCE OF THE INSTRUMENT AT THE TIME OF THE EVENT. THEREFORE, AN INSTRUMENT ISSUE CANNOT BE COMPLETELY RULED OUT AS CONTRIBUTING TO THE EVENT, ALTHOUGH, THERE IS NO EVIDENCE OR ANY SUGGESTION FROM THE CUSTOMER THAT THE INSTRUMENT WAS NOT PERFORMING AS INTENDED. PRE-ANALYTICAL SAMPLE PROCESSING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR, AS IT WAS NOT POSSIBLE TO ESTABLISH WHETHER THE CUSTOMER WAS FOLLOWING THE SAMPLE COLLECTION DEVICE MANUFACTURES 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. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS HSTNI LOT 1510.

    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 HSTNI RESULT WAS OBTAINED WHEN A SINGLE PATIENT SAMPLE WAS TESTED USING VITROS HSTNI LOT 1510 ON A VITROS XT7600 INTEGRATED SYSTEM. THE RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO A NON-VITROS BIOMERIEUX TROPONIN I RESULT FOR THE SAME PATIENT SAMPLE. PATIENT 1 SAMPLE 1 RESULT OF 149.05 NG/L (ABOVE THE 99TH PERCENTILE) VERSUS A BIOMERIEUX TROPONIN I RESULT OF NEGATIVE 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 HSTNI RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE HAS BEEN 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
    448047 VITROS IMMUNODIAGNOSTIC PRODUCTS HS TROPONIN I REAGENT PACK IN-VITRO DIAGNOSTICS MMI ORTHO-CLINICAL DIAGNOSTICS, INC. 1510

    Patients

    Seq Age Sex Outcome Treatment
    1