BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 23741676 · Received December 8, 2025

    Report

    Report Number
    1823260-2025-04979
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 19, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HBSAG REAGENT LOT NUMBER WAS 812808. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. FOR ALL OTHER REAGENTS, THE REAGENT LOT AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. CONTROLS WERE WITHIN RANGE PRIOR TO THE EVENT. THE FIELD SERVICE ENGINEER DETERMINED THE ISSUE WAS RELATED TO A REAGENT PROBE. THE ISSUE WAS RESOLVED BY THE ENGINEER AND THE DEVICE IS WORKING WITHIN SPECIFICATIONS AFTER SERVICE ACTIONS WERE PERFORMED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES COLLECTED FROM SEVEN PATIENTS AND TESTED ON THE COBAS 6000 E601 MODULE. RESULTS FOR THE FOLLOWING ASSAYS WERE QUESTIONED: ELECSYS HBSAG, ELECSYS ANTI-HBC, ELECSYS ANTI-HBE, ELECSYS HIV COMBI PT, AND ELECSYS ANTI-HBS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131314 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown