BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 24077867 · Received January 15, 2026

    Report

    Report Number
    1823260-2026-00179
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    December 26, 2025
    Report Date
    March 19, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630946198
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER STATED THAT THE QCS WERE WITHIN THE SPECIFIED RANGES. THE FIELD SERVICE ENGINEER INSPECTED THE MODULE AND DETERMINED THAT THE SAMPLE PROBE TIPS STACKED IN AN OVERFILLED WASTE CHUTE CAUSED THE EVENT. HE CLEANED THE WASTE LINERS AND WASTE CHUTES AND VERIFIED THE MODULE'S PERFORMANCE WITH SUCCESSFUL MECHANICAL AND PRECISION CHECKS. PRODUCT LABELING STATES, "CHANGING SOLID WASTE BOXES ON THE E 801 MODULE - WHEN ASSAYTIPS AND ASSAYCUPS HAVE BEEN CONSUMED AND DISPOSED OF, YOU CHANGE THE SOLID WASTE BOXES. A SOLID WASTE BOX IS ALSO CALLED WASTELINER. IF THE GREEN BUTTON FOR ONE OR BOTH SOLID WASTE BOXES IS FLASHING, YOU CHANGE THE FULL SOLID WASTE BOXES FOR NEW EMPTY ONES. WHEN TO CHANGE THE SOLID WASTE BOXES IS INDICATED ON THE REAGENT OVERVIEW DIALOG BOX OR BY AN INSTRUMENT ALARM." THE INVESTIGATION DETERMINED THAT INCOMPLETE CUSTOMER MAINTENANCE CAUSED THE EVENT. THE INVESTIGATION DETERMINED THAT THE CUSTOMER MAINTENANCE COMPLETION RESOLVED THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 87003600. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS VITAMIN B12 IMMUNOASSAY RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 E 801 MODULE. THE INITIAL RESULT FROM THE MODULE WAS <150 PG/ML. THE REPEAT RESULT FROM ANOTHER MODULE WAS 906 PG/ML THE QC AFTER THE PATIENT SAMPLE RUN WAS OUT OF RANGE, PROMPTING THE RERUN. THE REPEAT RESULT WAS DEEMED CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139682 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS 04015630946198

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown