BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 23199072 · Received October 2, 2025

    Report

    Report Number
    1823260-2025-04029
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    August 23, 2025
    Report Date
    October 2, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ELECSYS ESTRADIOL III ASSAY REAGENT LOT NUMBER IS 844594, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE CALIBRATION AND QC WERE BOTH WITHIN SPECIFICATION. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THE BEAD MIXING MOTOR AND A LOOSE REAGENT PROBE ARM WERE THE ROOT CAUSE OF THE EVENT. AFTER THE SERVICE ACTIONS WERE COMPLETED, THE ANALYZER IS WORKING WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A COMPONENT FAILURE (BEAD MIXER MOTOR AND/OR LOOSE REAGENT PROBE ARM). THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS ESTRADIOL III ASSAY RESULT FROM THE COBAS 6000 E601 MODULE FOR ONE PATIENT. ON (B)(6) 2025, THE INITIAL RESULT WAS 832.2 PG/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 13 PG/ML. THE REPEAT RESULT WAS CONSIDERED TO BE CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426739 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown