BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS STAT

    MDR report key: 22095183 · Received May 28, 2025

    Report

    Report Number
    1823260-2025-01628
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 8, 2025
    Report Date
    July 10, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E601 ANALYZER IS (B)(6). THE FIELD SERVICE ENGINEER CHECKED THE ANALYZER FLUIDICS. THE TEST WAS ASSIGNED TO THE OTHER MEASURING CELL OF THE ANALYZER. CALIBRATION AND CONTROLS WERE RUN. PATIENT SAMPLES WERE TESTED IN DUPLICATE AND THE RESULTS WERE COMPARABLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    ROCHE DIAGNOSTICS RECEIVED A CUSTOMER COMPLAINT REGARDING ALLEGED NON-REPRODUCIBLE ELECSYS TROPONIN T HS STAT ASSAY RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS 6000 E601 MODULE. THE CUSTOMER NOTED THEY WERE HAVING CALIBRATION ISSUES. AFTER PERFORMANCE OF MAINTENANCE, CALIBRATION AND CONTROLS WERE ACCEPTABLE. THE FIRST SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 8.27 NG/L AND WHEN REPEATED ON A SECOND ANALYZER, THE RESULT WAS 22.12 NG/L. THE SECOND SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 8.68 NG/L AND WHEN REPEATED ON A SECOND ANALYZER, THE RESULT WAS 14.44 NG/L. THE THIRD SAMPLE INITIALLY RESULTED IN A TROPONIN T VALUE OF 94.32 NG/L AND WHEN REPEATED ON A SECOND ANALYZER, THE RESULT WAS 241 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    327973 ELECSYS TROPONIN T HS STAT IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 827211

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown