BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 25026877 · Received April 29, 2026

    Report

    Report Number
    1823260-2026-01677
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 QC WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER CHECKED THE SAMPLE FOAM DETECTION (SFD) IMAGES AND OBSERVED BUBBLES IN THE PIPETTING ZONE. THE SAMPLE FOAM ALARM WAS TRIGGERED WHEN THE SAMPLE SHOWED BUBBLES IN THE PIPETTING ZONE OF THE NEEDLE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH ELECSYS TROPONIN T HS ASSAY ON A COBAS E 801 ANALYTICAL UNIT. INITIAL RESULT: 10.8 NG/L. ON (B)(6) 2026: REPEAT RESULT: 4.93 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84775 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 84737602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown