BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (DISK SYSTEM)

    MDR report key: 23223695 · Received October 6, 2025

    Report

    Report Number
    1823260-2025-04071
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 11, 2025
    Report Date
    November 13, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A COMPONENT FAILURE HAD CAUSED THE EVENT. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 844594, WITH AN EXPIRATION DATE OF 31-JAN-2026. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER, REPLACED SEVERAL TUBING SECTIONS ALONG WITH THE SAMPLE AND REAGENT PROBES, ADJUSTED THE LIQUID-LEVEL DETECTION (LLD), VERIFIED THE FUNCTIONALITY OF THE PINCH VALVES, AND CHECKED FOR DUST IN THE DETECTION AREA. ADDITIONALLY, HE CONDUCTED SUCCESSFUL MECHANICAL AND INSTRUMENT CHECKS. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULT FROM SIX PATIENT SAMPLES TESTED ON THE COBAS E 411 ANALYZER (DISK SYSTEM). ONE EXAMPLE OF DISCREPANT RESULTS FOR ONE PATIENT SAMPLE WAS PROVIDED: THE INITIAL RESULT FROM THE ANALYZER WAS 111.3 PMOL/L. THE REPEAT RESULT FROM ANOTHER LABORATORY WAS 69 PMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2575890 COBAS E 411 ANALYZER (DISK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown