BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 22725391 · Received August 6, 2025

    Report

    Report Number
    1823260-2025-02403
    Event Type
    Malfunction
    Date Received
    August 6, 2025
    Date of Event
    June 13, 2025
    Report Date
    August 25, 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

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

    Additional Manufacturer Narrative · 0

    DUE TO THE LIMITED INFORMATION PROVIDED, THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE. THERE WAS NO PRODUCT PROBLEM IDENTIFIED. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT PRESENT BECAUSE THE QC RESULTS BEFORE THE EVENT WERE WITHIN ACCEPTABLE RANGES.

    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 INITIAL RESULT WAS 11.1 NG/L AND THE REPEAT RESULT WAS 3 NG/L. PATIENT 2 INITIAL RESULT WAS 7.2 NG/L AND THE REPEAT RESULTS WERE 3.89 NG/L AND 3 NG/L. PATIENT 3 INITIAL RESULT WAS 7.37 NG/L AND THE REPEAT RESULT WAS 3 NG/L. PATIENT 4 INITIAL RESULT WAS 6.31 NG/L AND THE REPEAT RESULTS WERE 8.73 NG/L AND 9.22 NG/L. PATIENT 5 INITIAL RESULT WAS 11.2 NG/L AND THE REPEAT RESULTS WERE 5.75 NG/L AND 4.28 NG/L. PATIENT 6 INITIAL RESULT WAS 9.91 NG/L AND THE REPEAT RESULTS WERE 15.9 NG/L, 5.71 NG/L, AND 5.61 NG/L. PATIENT 7 INITIAL RESULT WAS 62.4 NG/L AND THE REPEAT RESULTS WERE 51.9 NG/L AND 51.8 NG/L. PATIENT 8 INITIAL RESULT WAS 11.9 NG/L AND THE REPEAT RESULT WAS 5.7 NG/L. PATIENT 9, ON (B)(6) 2025, INITIAL RESULT WAS 107 NG/L AND THE REPEAT RESULTS WERE 37.1 NG/L AND 36.4 NG/L. PATIENT 10, ON (B)(6) 2025, INITIAL RESULT WAS 399 NG/L AND THE REPEAT RESULTS WERE 10.9 NG/L AND 10.6 NG/L. PATIENT 11, ON (B)(6) 2025, INITIAL RESULT WAS 7.3 NG/L AND THE REPEAT RESULT WAS 10.5 NG/L. PATIENT 12, ON (B)(6) 2025, INITIAL RESULT WAS 445 NG/L AND THE REPEAT RESULT WAS 13.4 NG/L. AFTER RECENTRIFUGATION, THE RESULTS WERE 11 NG/L AND 10.8 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528793 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 82723201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown