BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)

    MDR report key: 23357129 · Received October 22, 2025

    Report

    Report Number
    1219913-2025-00192
    Event Type
    Malfunction
    Date Received
    October 22, 2025
    Date of Event
    October 15, 2025
    Report Date
    January 5, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    P100039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF REPRODUCIBLY REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION. SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    FOLLOWING ISSUANCE OF A SUPPLEMENTAL REPORT ON 14-NOV-2025, ADDITIONAL INFORMATION WAS RECEIVED IN CONNECTION WITH THIS PROBLEM INVESTIGATION. ADDITIONAL TESTING WAS PERFORMED. THE PATIENT SAMPLE WAS EVALUATED FOR THE PRESENCE OF HETEROPHILIC ANTIBODIES (HBT) AND NON-SPECIFIC ANTIBODIES (NABT) USING SCANTIBODIES BLOCK TUBES. RESULTS DID NOT INDICATE INTERFERENCE ATTRIBUTABLE TO HBT OR NABT AS THE CAUSE OF THE DISCORDANT ATELLICA IM AHBS2 RESULT. THE INVESTIGATION CONCLUSION AND CODING ARE UNCHANGED. BASED ON THE AVAILABLE EVIDENCE, THE DISCORDANT RESULT IS MOST CONSISTENT WITH A SAMPLE-SPECIFIC INTERFERENT OF UNKNOWN ORIGIN. THIS CONCLUSION IS SUPPORTED BY ELEVATED INITIAL RESULTS NOT CORROBORATED BY ADDITIONAL INFECTIOUS DISEASE TESTING, NEGATIVE INTERFERENCE TESTING (HBT AND NABT), AND INCONSISTENCY WITH PREVIOUSLY GENERATED PATIENT RESULTS. THE CUSTOMER REMAINS OPERATIONAL, AND NO SYSTEMIC PRODUCT PROBLEM WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION. MDR WAS INITIALLY SUBMITTED ON 22-OCT-2025. UPDATE, 13-NOV-2025: SIEMENS HAS CONCLUDED THE INVESTIGATION. A STRONGLY REACTIVE AHBS2 RESULT WAS OBTAINED FOR A PATIENT WHO HAD PREVIOUSLY TESTED NEGATIVE; THE RESULT WAS REPRODUCIBLE UPON REPEAT TESTING. THE PATIENT HAD NOT BEEN VACCINATED NOR TREATED WITH GAMMA GLOBULINS. SIEMENS REVIEWED THE AVAILABLE INFORMATION. REAGENT ISSUES WERE RULED OUT AS QUALITY CONTROL (QC) RESULTS WERE WITHIN EXPECTED RANGES, AND NO ISSUES WERE IDENTIFIED FOR ANY OTHER SAMPLES. ASSAY CALIBRATION DATA SHOWED VALID CALIBRATION PRIOR TO THE DISCORDANT MEASUREMENTS. THE PATIENT SAMPLES WAS NOT TESTED FOR THE PRESENCE OF HETEROPHILIC ANTIBODIES (USING HBT OR NABT TREATMENT), AND SAMPLES WERE DEPLETED AND UNAVAILABLE FOR ADDITIONAL TESTING. CONSEQUENTLY, SIEMENS IS UNABLE TO INVESTIGATE FURTHER. IT IS NOTED THAT THE ASSAY¿S INSTRUCTIONS FOR USE (IFU), UNDER CLINICAL SENSITIVITY AND SPECIFICITY, STATES THE 95% CONFIDENCE INTERVAL (CI) FOR RESOLVED RELATIVE SPECIFICITY AS 98.34% - 99.88%, SO A CERTAIN NUMBER OF FALSE POSITIVE RESULTS CAN BE EXPECTED. BASED ON THE AVAILABLE INFORMATION, A DEFINITIVE CAUSE FOR THE DISCORDANCE COULD NOT BE IDENTIFIED, BUT THE OBSERVATION IS CONSISTENT WITH A SAMPLE-SPECIFIC INTERFERENT OF UNKNOWN ORIGIN. THE CUSTOMER IS OPERATIONAL, AND NO SYSTEMIC PRODUCT PROBLEMS WERE IDENTIFIED. NOTE: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS WERE UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS WHICH WERE DISCORDANT RELATIVE TO CLINICAL EXPECTATION WHEN USING AHBS2 LOT: 176. A 31-YEAR-OLD FEMALE PATIENT UNDERGOING TREATMENT FOR HERPES PRODUCED REPRODUCIBLE REACTIVE ATELLICA IM AHBS2 RESULTS DESPITE LACK OF VACCINATION OR ADMINISTRATION OF GAMMA GLOBULINS. THE SAME PATIENT HAD TESTED NEGATIVE ON (B)(6) 2025. WHEN TESTED ON (B)(6), A STRONGLY REACTIVE RESULT WAS OBTAINED. THIS WAS QUESTIONED, AND THE SAMPLE WAS RE-TESTED TWO DAYS LATER ON AN ALTERNATE ATELLICA IM ANALYZER, WITH ESSENTIALLY THE SAME RESULT. THE REACTIVE RESULTS FOR THIS PATIENT ARE CONSIDERED ERRONEOUS. THERE ARE NO ALLEGATIONS OF ANY ADVERSE PATIENT CONSEQUENCES IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410505 ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 05988176 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female