BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 23255099 · Received October 9, 2025

    Report

    Report Number
    1823260-2025-04122
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 20, 2025
    Report Date
    October 9, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 844594. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER FOUND THE MIXER WAS BENT, AND THE SAMPLE PIPETTE WAS STUCK TO THE RIGHT SIDE. HE REPAIRED THE MIXER 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 ESTRADIOL RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULTS WERE ELEVATED. THE CUSTOMER LOADED A NEW REAGENT PACK, RECALIBRATED THE ASSAY, AND RAN QC. THE SAMPLES WERE THEN REPEATED. PATIENT 1 INITIAL RESULT WAS 163.0 PG/ML, AND THE REPEAT RESULT ON (B)(6) 2025 WAS 6.30 PG/ML. PATIENT 2 INITIAL RESULT WAS 322.1 PG/ML, AND THE REPEAT RESULT ON (B)(6) 2025 WAS 47.96 PG/ML. PATIENT 3 INITIAL RESULT WAS 363.5 PG/ML OR 365 PG/ML, AND THE REPEAT RESULT ON (B)(6) 2025 WAS 158 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2582752 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PATIENT 3- LEVOTIROXINA