BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-HBS II

    MDR report key: 21393274 · Received February 18, 2025

    Report

    Report Number
    1823260-2025-00451
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 23, 2025
    Report Date
    March 17, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOM
    PMA / PMN Number
    P010054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MEDWATCH, THE FIRST LINE OF B5 DESCRIBE EVENT OR PROBLEM SHOULD HAVE BEEN: "THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-HBS II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 - COBAS E 602 MODULE." INSTEAD OF: "THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-HBS II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 - COBAS E 602 MODULE OR A COBAS E 601 MODULE." THE QC WAS WITHIN SPECIFICATIONS. A GENERAL REAGENT ISSUE CAN BE EXCLUDED. BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE COBAS 8000 - COBAS E 602 MODULE IS 1207-02. THERE WAS NO SERIAL NUMBER PROVIDED FOR A COBAS E 601 MODULE. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-HBS II RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS 8000 - COBAS E 602 MODULE OR A COBAS E 601 MODULE. THE RESULT FROM THE E 602 OR E 601 MODULE WAS 7.91 IU/L OR 7.96 IU/L. THIS RESULT WAS DEEMED A FALSE NEGATIVE. THE RESULT FROM AN E 801 MODULE WAS 39.1 IU/L. THE REPORTER STATED THAT BOTH RESULTS WERE REPEATABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205582 ELECSYS ANTI-HBS II TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ROCHE DIAGNOSTICS 80423001

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female