BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 25200560 · Received May 18, 2026

    Report

    Report Number
    1823260-2026-01934
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    April 22, 2026
    Report Date
    May 18, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 854602. THE EXPIRATION DATE WAS REQUESTED BUT WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS CEA ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS 6000 E601 MODULE. THE INITIAL RESULT WAS 235 NG/ML. THE REPEAT RESULTS WERE 5 NG/ML ON BOTH OCCASIONS. THE SAMPLE WAS REPEATED AT ANOTHER LAB AND THE RESULTS WERE 225 NG/ML AND 237 NG/ML. NO ERRONEOUS RESULTS WERE REPORTED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76563 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1