BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS HBSAG II

    MDR report key: 23099617 · Received September 19, 2025

    Report

    Report Number
    1823260-2025-03255
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    October 13, 2021
    Report Date
    September 19, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOM
    UDI-DI
    07613336168103
    PMA / PMN Number
    P160019/S010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HBSAG G2 REAGENT EXPIRATION DATE WAS NOT PROVIDED. THE REPORTED EVENT OCCURRED ON A COBAS E 801 MODULE (SERIAL NUMBER: (B)(6)). THE INVESTIGATION DETERMINED THAT THE HBSAG G2 ELECSYS E2G 300 V2 ASSAY PERFORMED WITHIN SPECIFICATIONS. A GENERAL REAGENT ISSUE WAS EXCLUDED AS A POTENTIAL CAUSE. THE INVESTIGATION REVEALED THAT THE MEASURING CELLS OF THE ANALYZER WERE OUT OF SPECIFICATION AT THE TIME OF THE REPORTED EVENT, AS THEY HAD NOT BEEN REPLACED IN OVER 22 MONTHS, EXCEEDING THE RECOMMENDED REPLACEMENT INTERVAL OF 12 MONTHS OR (B)(4) TESTS. ALL PATIENT SAMPLES WERE RETESTED ON A COBAS E 801 ANALYZER USING A DIFFERENT REAGENT LOT, AND ALL RESULTS WERE DETERMINED TO BE NON-REACTIVE. THE MEASURING CELLS WERE REPLACED ON (B)(6) 2021, AND THE ANALYZER WAS RETURNED TO OPERATION. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER ALLEGED DISCREPANT POSITIVE RESULTS FOR THE HBSAG G2 ELECSYS E2G 300 V2 ASSAY ON THE COBAS E 801 MODULE FOR THREE PATIENT SAMPLES. THE CUSTOMER IS USING THE ASSAY IN AN E-FLOW WORKFLOW. FOR PATIENT 1, A SAMPLE COLLECTED IN (B)(6) YIELDED A REACTIVE RESULT OF 2.800 COI ON THE FIRST RUN, A NON-REACTIVE RESULT OF 0.412 COI ON THE SECOND RUN, AND A REACTIVE RESULT OF 1.100 COI ON THE THIRD RUN. A SUBSEQUENT SAMPLE COLLECTED IN OCTOBER YIELDED A REACTIVE RESULT OF 3.010 COI ON THE FIRST RUN, A NON-REACTIVE RESULT OF 0.396 COI ON THE SECOND RUN, AND A REACTIVE RESULT OF 1.210 COI ON THE THIRD RUN. THE SAMPLE WAS CONFIRMED NEGATIVE BY AN ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) METHOD AT A PUBLIC HEALTH LABORATORY AND WAS ALSO NON-REACTIVE FOR HEPATITIS B CORE (IGM AND IGG). THE PATIENT HAD A HIGH ANTI-HEPATITIS B SURFACE ANTIGEN (A-HBS) TITER OF 280875 IU/L AND WAS REPORTED TO HAVE BEEN VACCINATED AGAINST HEPATITIS B. FOR PATIENT 2, THE SAMPLE YIELDED A REACTIVE RESULT OF 1.63 COI ON THE FIRST RUN, A NON-REACTIVE RESULT OF 0.433 COI ON THE SECOND RUN, AND A NON-REACTIVE RESULT OF 0.980 COI ON THE THIRD RUN. THE A-HBS TITER WAS 210340 IU/L. FOR PATIENT 3, THE SAMPLE YIELDED A REACTIVE RESULT OF 1.810 COI ON THE FIRST RUN, A NON-REACTIVE RESULT OF 0.419 COI ON THE SECOND RUN, AND A REACTIVE RESULT OF 1.190 COI ON THE THIRD RUN. THE A-HBS TITER WAS 264180 IU/L. ALL SAMPLES WERE CONFIRMED NEGATIVE BY ELISA AT A PUBLIC HEALTH LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397175 ELECSYS HBSAG II TEST, HEPATITIS B LOM ROCHE DIAGNOSTICS 525728 07613336168103

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown