BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 25232716 · Received May 20, 2026

    Report

    Report Number
    1823260-2026-01988
    Event Type
    Malfunction
    Date Received
    May 20, 2026
    Date of Event
    April 24, 2026
    Report Date
    May 20, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 545 NG/L. A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND THE RESULT WAS 15 NG/L. THE DOCTOR QUESTIONED THE RESULT FROM THE ORIGINAL SAMPLE, WHICH PROMPTED THE CUSTOMER TO PERFORM REPEAT TESTING. THE ORIGINAL SAMPLE WAS REPEATED ON THE INITIAL ANALYZER, RESULTING IN A VALUE OF 14.9 NG/L. A MEASUREMENT PERFORMED WITH ANOTHER ANALYZER CONFIRMED THE REPEAT RESULT. THE CUSTOMER ALSO PROVIDED AN INITIAL RESULT OF 546 NG/L WITH A REPEAT RESULT OF 7.5 NG/L FROM ANOTHER ANALYZER. CLARIFICATION ON IF THESE ARE ADDITIONAL RESULTS FROM THE SAME SAMPLE WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472938 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 827232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown