BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 22714434 · Received August 5, 2025

    Report

    Report Number
    1823260-2025-02390
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 12, 2025
    Report Date
    August 5, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 801917. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATION NOTED THE ANALYZER'S VOLTAGES, THE MIXER FORMING AIR BUBBLES IN THE REAGENT KIT, AND CRYSTALLIZATION AND ADJUSTMENTS IN THE SIPPER. THIS IS RESOLVED BY THE USER AND LOCAL MAINTENANCE. THE INVESTIGATION REVIEWED THE QC DATA, AND THE RESULTS ARE WITHIN THE SPECIFIED RANGES. A GENERAL REAGENT PROBLEM WAS NOT PRESENT BECAUSE THE QCS BEFORE THE EVENT ARE WITHIN THE SPECIFIED RANGES, AND ISOLATED NON-REPRODUCIBLE RESULTS DO NOT REPRESENT A GENERAL MALFUNCTION OF THE ASSAY.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS FT3 III RESULT FROM A PATIENT SAMPLE TESTED ON THE COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS >50.00 PMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 2.20 PMOL/L WITH A DATA FLAG. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2684770 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown