BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 24441777 · Received February 25, 2026

    Report

    Report Number
    1823260-2026-00664
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    January 16, 2026
    Report Date
    March 19, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE ALARM TRACE FOR ANALYZER (B)(6) SHOWED SEVERAL SAMPLE QUALITY RELATED ALARMS. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    NEW SAMPLE RESULTS WERE PROVIDED BY THE AFFILIATE. ON (B)(6) 2026, SAMPLE 13 HAD AN INITIAL RESULT OF 40.5 NG/L. THE REPEAT RESULT WAS 34.0 NG/L. THE ROOT CAUSE OF THE EVENT WAS FOUND TO BE CONSISTENT WITH PRE-ANALYTICAL SAMPLE HANDLING ISSUES. NO PRODUCT PROBLEM WAS IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FOR 12 PATIENT SAMPLES ON 3 COBAS E 801 ANALYTICAL UNITS. ON (B)(6) 2026, SAMPLE 1 HAD AN INITIAL RESULT OF 9.16 NG/L WITH FLAG ON ANALYZER (B)(6). THE REPEAT RESULT WAS 6.18 NG/L. ON (B)(6) 2026, SAMPLE 2 HAD AN INITIAL RESULT OF 62.3 NG/L ON ANALYZER (B)(6). THE REPEAT RESULT WAS 17.1 NG/L. ON (B)(6) 2026, SAMPLE 3 HAD AN INITIAL RESULT OF 225.0 NG/L ON ANALYZER (B)(6). THE REPEAT RESULT WAS 92.8 NG/L. ON (B)(6) 2026, SAMPLE 4 HAD AN INITIAL RESULT OF 12.6 NG/L ON ANALYZER (B)(6). THE SAMPLE WAS REPEATED TWICE AND THE REPEAT RESULTS WERE 4.60 NG/L AND 4.99 NG/L. ON (B)(6) 2026, SAMPLE 5 HAD AN INITIAL RESULT OF 120 NG/L ON ANALYZER (B)(6). THE SAMPLE WAS REPEATED FOUR AND THE REPEAT RESULTS WERE 153 NG/L, 137 NG/L, 150 NG/L, AND 157 NG/L. ON (B)(6) 2026, SAMPLE 6 HAD AN INITIAL RESULT OF 72.9 NG/L ON ANALYZER (B)(6). THE SAMPLE WAS REPEATED TWICE AND THE REPEAT RESULTS WERE 84.0 NG/L AND 90.8 NG/L. ON (B)(6) 2026, SAMPLE 7 HAD AN INITIAL RESULT OF 31.2 NG/L ON ANALYZER (B)(6). THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 8.20 NG/L AND 8.88 NG/L. ON (B)(6) 2026, SAMPLE 8 HAD AN INITIAL RESULT OF 272 NG/L ON ANALYZER (B)(6). THE SAMPLE WAS REPEATED TWICE ON ANALYZER (B)(6) AND THE RESULTS WERE 36.6 NG/L AND 34.9 NG/L. ON (B)(6) 2026, SAMPLE 9 HAD AN INITIAL RESULT OF 17.7 NG/L ON ANALYZER (B)(6). THE SAMPLE WAS REPEATED AND THE RESULT WAS 6.15 NG/L. THE SAMPLE WAS REPEATED ON ANALYZER (B)(6) AND THE RESULT WAS 8.18 NG/L. ON (B)(6) 2026, SAMPLE 10 HAD AN INITIAL RESULT OF 4.89 NG/L ON ANALYZER (B)(6). THE SAMPLE WAS REPEATED ON ANALYZER (B)(6) AND THE RESULT WAS 7.77 NG/L. ON (B)(6) 2026, SAMPLE 11 HAD AN INITIAL RESULT OF 7.75 NG/L ON ANALYZER (B)(6). THE REPEAT RESULT WAS 4.28 NG/L. ON (B)(6) 2026, SAMPLE 12 HAD AN INITIAL RESULT OF 510 NG/L ON ANALYZER (B)(6). THE SAMPLE WAS REPEATED TWICE AND THE REPEAT RESULTS WERE 26.3 NG/L AND 26.6 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624648 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 84737601

    Patients

    Seq Age Sex Outcome Treatment
    1