BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 25302847 · Received May 27, 2026

    Report

    Report Number
    1823260-2026-02078
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630937103
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 924462. THE EXPIRATION DATE WAS NOT PROVIDED. THE SERIAL NUMBER FOR MODULE 2 IS (B)(6). THE QC WAS ACCEPTABLE. THE SERVICE REPRESENTATIVE FOUND THAT THE PINCH VALVE WAS SEVERELY DETERIORATED. HE REPLACED BOTH PINCH VALVES AND ADJUSTED THE PIPETTE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS TROPONIN T HS STAT RESULTS FOR 1 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (DISK SYSTEM). THE INITIAL RESULT WAS 15.61 NG/L. THE SAMPLE WAS REPEATED ON ANOTHER MODULE (MODULE 2), AND THE RESULT WAS 4.91 NG/L. THIS RESULT WAS CORRECT. ON (B)(6) 2026, THE SAMPLE WAS REPEATED. THE SAMPLE WAS TESTED ON THE SAME MODULE AS THE INITIAL RESULT, AND THE RESULT WAS 4.46 NG/L. THE RESULT ON MODULE 2 WAS 4.91 NG/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600873 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630937103

    Patients

    Seq Age Sex Outcome Treatment
    1