BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 22123691 · Received June 2, 2025

    Report

    Report Number
    1823260-2025-01694
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 8, 2025
    Report Date
    June 27, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT'S LOT NUMBER IS 844594. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER FOUND HIGH BLANK CELL REAGENT SIGNALS. HE CLEANED ALL OF THE PROBES, WASH STATIONS, INCUBATOR, AND OPEN/CLOSE MECHANISMS. HE FOUND THE SIPPER PROBE WAS NOT CENTERED IN THE WASH STATION AND ADJUSTED THE SIPPER RINSING POSITION. HE PERFORMED LIQUID FLOW CLEANING, CHECKED THE VOLTAGE, AND REMOVED BUBBLES FROM THE BEAD CARTRIDGE. HE ADJUSTED THE PHOTOMULTIPLIER HIGH VOLTAGE AND PERFORMED A BLANKCELL CALIBRATION. HE PRIMED THE SAMPLE/REAGENT AND SIPPER PROBES, RAN MEASURING CELL PREPARATIONS, AND RAN PERFORMANCE TESTING THAT WAS WITHIN SPECIFICATION. THE CUSTOMER COMPLETED CALIBRATIONS AND QC WITH RESULTS WITHIN EXPECTED RANGES. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULTS FOR 1 PATIENT ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE INITIAL RESULT WAS 3000 PG/ML WITH A DATA FLAG, AND THE REPEATED RESULT WAS 1754 PG/ML. THE SAMPLE WAS REPEATED, AND THE RESULT WAS >3000 PG/ML. A 1:10 DILUTION WAS PERFORMED, AND THE RESULT WAS 1818 PG/ML. THE SAMPLE WAS REPEATED BECAUSE THE INITIAL RESULT HAD A DATA FLAG. THE RESULT OF 1754 PG/ML WAS BELIEVED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603730 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown