BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E 801 MODULE

    MDR report key: 23405436 · Received October 28, 2025

    Report

    Report Number
    1823260-2025-04381
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 8, 2025
    Report Date
    October 28, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CA 19-9 REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE CEA REAGENT LOT NUMBER WAS 840135 WITH AN EXPIRATION DATE OF 31-MAY-2026. THE CA 125 REAGENT LOT NUMBER WAS 831061 WITH AN EXPIRATION DATE OF 31-MAR-2026. ON (B)(6) 2025, THE FSE RETURNED TO THE CUSTOMER SITE AND FOUND DEGRADATION OF THE SIPPER NOZZLE AND LIQUID LEAKING FROM THE SAMPLE PROBE MECHANISM. DUE TO THE DEGRADATION OF THE SIPPER NOZZLE, THE DIAMETER OF THE HOLE WAS WIDENED. THE FSE IDENTIFIED A HOLE IN THE TUBE CONNECTOR AND REPLACED THE SAMPLING UNIT. QC WAS ACCEPTABLE. REPRODUCIBILITY TESTING WAS PERFORMED WITH ACCEPTABLE RESULTS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE RESULTS FOR MULTIPLE PATIENT SAMPLES AND MULTIPLE ASSAYS ON A COBAS 8000 E 801 MODULE. DISCREPANT LOW RESULTS WERE PROVIDED FOR 7 PATIENT SAMPLES TESTED FOR ELECSYS CA 19-9 (CA 19-9), ELECSYS CEA (CEA), AND CA 125. PATIENT 1 INITIAL CA 19-9 RESULT WAS 49.9 U/ML. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 26 U/ML AND 51 U/ML. ON (B)(6) 2025, THE FIELD SERVICE ENGINEER (FSE) FOUND AN ISSUE WITH THE SIPPER NOZZLES AND REPLACED THEM. THE FSE PERFORMED AN INSTRUMENT CHECK, AND THE RESULTS WERE WITHIN SPECIFICATION. THE ISSUE WAS NOT RESOLVED, AND THE CUSTOMER COMPLAINED OF ADDITIONAL QUESTIONABLE RESULTS. PATIENT 2 INITIAL CEA RESULT WAS 8.9 NG/ML. THE REPEAT RESULT WAS 16.5 NG/ML. PATIENT 3 INITIAL CEA RESULT WAS 4.5 NG/ML. THE REPEAT RESULT WAS 10.5 NG/ML. PATIENT 4 INITIAL CEA RESULT WAS 412.0 NG/ML. THE REPEAT RESULT WAS 833.0 NG/ML. PATIENT 5 INITIAL CEA RESULT WAS 1.5 NG/ML. THE REPEAT RESULT WAS 2.9 NG/ML. PATIENT 6 INITIAL CEA RESULT WAS 1.9 NG/ML. THE REPEAT RESULT WAS 2.7 NG/ML. PATIENT 7 INITIAL CA 125 RESULT WAS 36 U/ML. THE REPEAT RESULT WAS 51 U/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1981705 COBAS 8000 E 801 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown