BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 22104791 · Received May 29, 2025

    Report

    Report Number
    1823260-2025-01643
    Event Type
    Malfunction
    Date Received
    May 29, 2025
    Date of Event
    May 6, 2025
    Report Date
    July 17, 2025
    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

    RESULTS REPORTED FOR PATIENT 5 WERE APPROXIMATIONS; EXACT RESULTS WERE PROVIDED ON 02-JUN-2025. THE INITIAL RESULT WAS 18.5 NG/L, THE 1ST REPEAT RESULT WAS 16.1 NG/L, AND THE 2ND REPEAT RESULT WAS 15.1 NG/L. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    PATIENT 6'S INITIAL RESULT ON (B)(6) 2025 WAS 2702 NG/L. THE 1ST REPEAT RESULT WAS 3307 NG/L. THE 2ND REPEAT RESULT WAS 3513 NG/L. PATIENT 7'S INITIAL RESULT ON (B)(6) 2025 WAS 28.3 NG/L. THE 1ST REPEAT RESULT WAS 18.0 NG/L. THE 2ND REPEAT RESULT WAS 17.5 NG/L. THE RESULT OF 18 NG/L WAS DEEMED TO BE CORRECT. PATIENT 8'S INITIAL RESULT ON (B)(6) 2025 WAS 10.5 NG/L. THE 1ST REPEAT RESULT WAS 6.25 NG/L. THE 2ND REPEAT RESULT WAS 6.89 NG/L. PATIENT 9'S INITIAL RESULT ON (B)(6) 2025 WAS 25.4 NG/L. THE 1ST REPEAT RESULT WAS 31.6 NG/L. THE 2ND REPEAT RESULT WAS 33.7 NG/L. THE REAGENT LOT USED FOR THESE PATIENTS WAS 827232. THERE WASN'T A CALIBRATION INFLUENCE OBSERVED. QC WAS WITHIN RANGE BEFORE THE EVENT OCCURRED. THEREFORE, A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT. NO RELEVANT ALARMS WERE OBSERVED. UPON INVESTIGATION, THERE WERE NO ERRORS OBSERVED IN THE SAMPLE HANDLING. IN IMAGES OF THE SAMPLES PROVIDED, THERE WERE SOME ABNORMALITIES, BUT THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. PATIENT 1'S INITIAL RESULT WAS 32.0 NG/L, AND THE 1ST REPEAT RESULT WAS 23.1 NG/L, AND A 2ND REPEAT RESULT OF 23.9 NG/L. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 19.7 NG/L, AND THE 1ST REPEAT RESULT WAS 16.7 NG/L, AND A 2ND REPEAT RESULT OF 15.9 NG/L. PATIENT 3'S INITIAL RESULT ON (B)(6) 2025 WAS 12.4 NG/L, AND THE 1ST REPEAT RESULT WAS 18.2 NG/L, AND A 2ND REPEAT RESULT OF 11.8 NG/L. PATIENT 4'S INITIAL RESULT ON (B)(6) 2025 WAS 13.9 NG/L, AND THE 1ST REPEAT RESULT WAS 11 NG/L, AND A 2ND REPEAT RESULT OF 10.9 NG/L. PATIENT 5'S INITIAL RESULT ON (B)(6) 2025 WAS 19 NG/L, AND THE 1ST REPEAT RESULT WAS 15 NG/L, AND A 2ND REPEAT RESULT WAS 16 NG/L. THE RESULT OF 16 NG/L WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540194 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 81184801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown