BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E 411 ANALYZER (RACK SYSTEM)

    MDR report key: 23649589 · Received November 25, 2025

    Report

    Report Number
    1823260-2025-04850
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924721
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ESTABLISHMENT NAME: (B)(6). THE HIV DUO REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE ELECSYS HIV COMBI PT REAGENT LOT NUMBER IS 840005 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE ELECSYS HBSAG II REAGENT LOT NUMBER IS 834976 WITH AN EXPIRATION DATE OF 31-AUG-2026. THE CALIBRATION WAS ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE FIELD SERVICE REPRESENTATIVE PERFORMED MAINTENANCE, REPLACED CELLS, ADJUSTED THE WATER FLOW, AND INSPECTED THE EQUIPMENT. HE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE TEST RESULTS FOR 2 PATIENT SAMPLE ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE AFFECTED ASSAYS WERE ELECSYS HBSAG II, ELECSYS HIV COMBI PT, AND ELECSYS HIV DUO. THE INITIAL HBSAG RESULT WAS 1.74 COI (REACTIVE), AND THE INITIAL HIV COMBI RESULT WAS 1.14 COI (REACTIVE). THE RESULTS DIDN'T MATCH THE PATIENT'S CLINICAL HISTORY, AND THE SAMPLE WAS REPEATED. THE SAMPLE WAS REPEATED ON ANOTHER MODULE (COBAS PURE E402). THE REPEATED HBSAG RESULT WAS 0.21 COI (NON-REACTIVE), AND THE HIV DUO RESULT WAS 0.19 COI (NON-REACTIVE). THE SAMPLE WAS REPEATED ON THE COBAS PURE E402 AGAIN, AND THE RESULTS WERE BOTH NON-REACTIVE. THE NUMERICAL RESULTS FOR THE SECOND REPEAT WERE NOT PROVIDED. THE EXPECTED RESULTS FOR THIS PATIENT WERE NON-REACTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2568449 COBAS E 411 ANALYZER (RACK SYSTEM) IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E 411 04015630924721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female