BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM HBC TOTAL 2 (HBCT2)

    MDR report key: 24670095 · Received March 23, 2026

    Report

    Report Number
    1219913-2026-00060
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    March 5, 2026
    Report Date
    May 20, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD.
    Product Code
    SEI
    UDI-DI
    00630414604138
    PMA / PMN Number
    P210019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER OBTAINED OF A NON-REACTIVE (NEGATIVE) PATIENT RESULT USING ATELLICA IM HBC TOTAL 2 (HBCT2) LOT 017. THE RESULT WAS NOT REPORTED AS THE PATIENT WAS KNOWN TO HAVE HEPATITIS B. THE SAMPLE WAS RETESTED USING AN ALTERNATE METHOD AND THE RESULT WAS REACTIVE (POSITIVE) AS EXPECTED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES, THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." FINDINGS." "PATIENT SAMPLES MAY CONTAIN HETEROPHILIC ANTIBODIES THAT COULD REACT IN IMMUNOASSAYS TO GIVE FALSELY ELEVATED OR DEPRESSED RESULTS. THIS ASSAY IS DESIGNED TO MINIMIZE INTERFERENCE FROM HETEROPHILIC ANTIBODIES. ADDITIONAL INFORMATION MAY BE REQUIRED FOR DIAGNOSIS." SIEMENS IS INVESTIGATING.

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED OF A NON-REACTIVE (NEGATIVE) PATIENT RESULT USING ATELLICA IM HBC TOTAL 2 (HBCT2) LOT 017. THE RESULT WAS NOT REPORTED AS THE PATIENT WAS KNOWN TO HAVE HEPATITIS B. THE SAMPLE WAS RETESTED USING AN ALTERNATE METHOD AND THE RESULT WAS REACTIVE (POSITIVE) AS EXPECTED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273276 ATELLICA IM HBC TOTAL 2 (HBCT2) QUALITATIVE AND QUANTITATIVE HEPATITIS B VIRUS ANTIBODY ASSAYS SEI SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD. N/A 06403017 00630414604138

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male