BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 23881969 · Received December 23, 2025

    Report

    Report Number
    1823260-2025-05343
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 10, 2025
    Report Date
    March 3, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER REPLACED THE SIPPER AND MEASURING CELL AND CLEANED THE LIQUID FLOW PATH. HE CONFIRMED THAT THE ANALYZER WAS WORKING ACCORDING TO SPECIFICATION AFTER SERVICE. THE INVESTIGATION WAS UNABLE TO DETERMINE A SPECIFIC ROOT CAUSE, AS MULTIPLE PARTS WERE REPLACED AND CLEANED. THE ISSUE WAS RESOLVED AFTER THE SERVICE ACTIONS.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER WAS 850880. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CA19-9 RESULTS FROM THE COBAS E 801 MODULE. THE INITIAL RESULT WAS 19.4 U/ML, AND THE REPEAT RESULT WAS 35.5 U/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2477522 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown