BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 22025966 · Received May 15, 2025

    Report

    Report Number
    1823260-2025-01487
    Event Type
    Malfunction
    Date Received
    May 15, 2025
    Date of Event
    April 17, 2025
    Report Date
    June 13, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS E 801 ANALYTICAL UNIT IS (B)(6). THE CALIBRATION AND QC WERE WITHIN THE SPECIFIED RANGES. THE ANALYZER'S ALARM FILES SHOWED A SAMPLE CLOT DETECTION ALARM, INDICATING A POSSIBLE SAMPLE QUALITY ISSUE. THE SAMPLE FOAM DETECTION (SFD) CAMERA IMAGE SHOWED A FILM OF DUST ON THE ANALYZER SURFACE. THE SFD IMAGE OF THE PATIENT SAMPLE WAS UNREMARKABLE, BUT DUST WAS VISIBLE ON THE GRIPPER WHEELS AROUND THE TUBE. THESE CAN LEAD TO QUESTIONABLE RESULTS. A GENERAL REAGENT OR ANALYZER PROBLEM WAS NOT DETECTED BECAUSE THE QCS BEFORE THE EVENT WERE WITHIN THE SPECIFIED RANGES. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE TROPONIN T HS ELECSYS ASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 48.1 NG/L. THE REPEAT RESULT WAS 12.6 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754987 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 81184801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown