BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 22080396 · Received May 23, 2025

    Report

    Report Number
    1823260-2025-01595
    Event Type
    Malfunction
    Date Received
    May 23, 2025
    Date of Event
    April 28, 2025
    Report Date
    June 3, 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

    PATIENT 9'S INITIAL RESULT ON (B)(6) 2025 WAS 10 NG/L, THE 1ST REPEAT RESULT WAS 17 NG/L, AND THE 2ND REPEAT RESULT WAS 10NG/L. QC AND CALIBRATION WERE PASSING BEFORE THE EVENT OCCURRED, THEREFORE, A GENERAL REAGENT ISSUE IS NOT PRESENT. NO RELEVANT ALARMS WERE OBSERVED. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. THE SAMPLES ARE NOT INVERTED BEFORE CENTRIFUGATION.

    Additional Manufacturer Narrative · 0

    THE COBAS E 801 ANALYTICAL UNIT 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 FROM THE COBAS E 801 ANALYTICAL UNIT. PATIENT 1'S INITIAL RESULT WAS 17.6 NG/L, AND THE REPEAT RESULT WAS 14.5 NG/L. PATIENT 2'S INITIAL RESULT ON (B)(6) 2025 WAS 47.7 NG/L, AND THE 1ST REPEAT RESULT WAS 39.4 NG/L, AND A 2ND REPEAT RESULT OF 39.8 NG/L. PATIENT 3'S INITIAL RESULT ON (B)(6) 2025 WAS 102 NG/L, AND THE 1ST REPEAT RESULT WAS 54.9 NG/L, AND A 2ND REPEAT RESULT OF 55.0 NG/L. PATIENT 4'S INITIAL RESULT ON (B)(6) 2025 WAS 20.4 NG/L, AND THE 1ST REPEAT RESULT WAS 14.2 NG/L. WHEN REPEATED ON A SECOND ANALYZER, THE RESULT WAS 13.8 NG/L. PATIENT 5'S INITIAL RESULT ON (B)(6) 2025 WAS 26.3 NG/L, AND THE 1ST REPEAT RESULT WAS 19.3 NG/L, AND A 2ND REPEAT RESULT OF 20 NG/L. PATIENT 6'S INITIAL RESULT ON (B)(6) 2025 WAS 4542 NG/L. THE 1ST REPEAT RESULT WAS 5975 NG/L. THE 2ND REPEAT RESULT WAS 6244 NG/L. THE 3RD REPEAT RESULT WAS 6297 NG/L. PATIENT 7'S INITIAL RESULT ON (B)(6) 2025 WAS 3.69 NG/L. THE 1ST REPEAT RESULT WAS 5.08 NG/L. THE 2ND REPEAT RESULT WAS 11.5 NG/L. THE 3RD REPEAT RESULT WAS 3.95 NG/L. PATIENT 8'S INITIAL RESULT ON (B)(6) 2025 WAS 17.6 NG/L. THE 1ST REPEAT RESULT WAS 26.3 NG/L. THE 2ND REPEAT RESULT WAS 30.6 NG/L. THE 3RD REPEAT RESULT WAS 18 NG/L. THE 4TH REPEAT RESULT WAS 19.2 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818596 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 811848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown