BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 22903878 · Received August 27, 2025

    Report

    Report Number
    1823260-2025-02628
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    April 24, 2025
    Report Date
    August 27, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER FOR 1 UNIT IS (B)(6). THE SERIAL NUMBERS FOR THE OTHER TWO UNITS WERE NOT PROVIDED. PATIENT SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION BUT COULD NOT BE PROVIDED. AS THE SAMPLE WAS NO LONGER AVAILABLE, IT WAS NOT POSSIBLE TO DETERMINE A SPECIFIC ROOT CAUSE. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH ELECSYS TROPONIN T HS RESULTS FROM THREE COBAS E 801 ANALYTICAL UNITS FOR ONE PATIENT. THE INITIAL RESULT ON (B)(6) 2025 WAS 3666.0 PG/ML ON ANALYTICAL UNIT C. THE RESULT FROM ANOTHER COBAS PRO ANALYZER, UNIT B, WAS 3654.0 PG/ML, WITH ANOTHER RESULT ON (B)(6) 2025 OF 3804.0 PG/ML. ON (B)(6) 2025, THERE WAS A RESULT OF 3421.0 PG/ML, ALSO FROM ANALYZER UNIT B. ON (B)(6) 2025, FROM ANOTHER COBAS PRO, UNIT A, THE RESULT WAS 3765.0 PG/ML. THE SAMPLE WAS THEN SENT TO AN EXTERNAL LAB, AND THE TROPONIN STAT RESULT WAS 3719 PG/ML, USING ANOTHER COBAS E801. ON (B)(6) 2025, THERE WAS A RESULT OF 3713.0 PG/ML FROM ANALYZER UNIT B. THE SAMPLE WAS SENT TO AN EXTERNAL LAB FOR A TROPONIN I TEST ON ANOTHER PLATFORM THAT WAS NOT SPECIFIED, AND THE RESULT WAS 2.3 PG/ML. THE ELEVATED RESULTS WERE FOUND TO BE QUESTIONABLE BECAUSE THEY DID NOT MATCH THE PATIENT'S CURRENT CLINICAL PICTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251247 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 795168

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Male