BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 22793815 · Received August 13, 2025

    Report

    Report Number
    1823260-2025-02469
    Event Type
    Injury
    Date Received
    August 13, 2025
    Date of Event
    July 14, 2025
    Report Date
    September 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630924714
    PMA / PMN Number
    K060373
    Adverse Event
    Yes
    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 G2 ELECSYS COBAS E 100 V2 REAGENT LOT NUMBER IS 812808, AND THE EXPIRATION DATE IS 31-MAY-2026. THE ELECSYS HBEAG REAGENT LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE REPORTED TO BE WITHIN SPECIFICATION. THERE WERE SAMPLE PIPETTING ALARMS PRESENT IN THE ALARM TRACE REPORT. A FIELD APPLICATION SPECIALIST (FAS) DETERMINED THAT THERE WAS AN EXPIRED PROBEWASH SOLUTION, WHICH IS USED TO CLEAN THE REAGENT PROBE AND CAN AFFECT REAGENT CARRYOVER. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS MISSING OR INCOMPLETE CUSTOMER MAINTENANCE. THE CORRECT MAINTENANCE WAS PERFORMED, AND THE ANALYZER IS WORKING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE FALSE-POSITIVE RESULTS FOR ELECSYS HBSAG AND ELECSYS HBEAG FROM THE COBAS 6000 E601 MODULE. IT WAS ALLEGED THAT ON AN UNKNOWN DATE, THE PATIENT WAS MISTAKENLY DIAGNOSED WITH HEPATITIS B AND WAS USING A DIALYSIS MACHINE DEDICATED TO HEPATITIS B PATIENTS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. WITH SAMPLE 1, IN (B)(6) OF 2024, THE PATIENT REPORTEDLY HAD A NON-REACTIVE RESULT FOR HBSAG. WITH SAMPLE 2, ON (B)(6) 2025, THE PATIENT REPORTEDLY HAD A REACTIVE RESULT FOR HBSAG. WITH SAMPLE 2, FROM (B)(6) 2025, ON (B)(6) 2025, THE LAB COMPLETED REFLEX TESTING WITH THE HBEAG TEST, AND IT WAS REPORTEDLY ALSO REACTIVE. WITH SAMPLE 3, ON (B)(6) 2025, IT WAS REPORTED THAT THE PATIENT HAD A NON-REACTIVE HBSAG AND A REACTIVE RESULT OF AHBS. ON (B)(6) 2025, WITH SAMPLE 4, IT WAS REPORTED THAT A SAMPLE USED FOR MOLECULAR TESTING WAS USED AND REMAINED NON-REACTIVE FOR HBSAG. THE SAME SAMPLE WAS REPORTEDLY ALSO USED TO TEST THE VIRAL LOAD, WHICH WAS NOT DETECTED. WITH SAMPLE 5, ON (B)(6) 2025, IT WAS REPORTED THAT THE SAMPLE WAS NON-REACTIVE FOR HBSAG, NON-REACTIVE FOR HBEAG, NON-REACTIVE FOR AHBE, NON-REACTIVE FOR AHBCORE TOTAL, AND NON-REACTIVE FOR AHBCORE IGM, WHILE THE AHBS TITER WAS REACTIVE. THERE HAVE NOT BEEN ANY ADDITIONAL RESULTS FROM THE PATIENT PROVIDED AFTER THE USE OF THE DIALYSIS MACHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563987 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS E601 04015630924714

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other