BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16448436 · Received February 27, 2023

    Report

    Report Number
    1219913-2023-00040
    Event Type
    Malfunction
    Date Received
    February 27, 2023
    Date of Event
    February 16, 2023
    Report Date
    May 11, 2023
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    P100039-S005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF POSITIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. ON (B)(6) 2023, A POSITIVE AHBS2 RESULT OF 27 MIU/ML WAS OBTAINED FOR A FEMALE CHRONIC HEPATITIS PATIENT WHO HAS BEEN UNDERGOING ANTIVIRAL TREATMENT. THIS INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN. ADDITIONAL TESTING WAS PERFORMED ON THIS SAMPLE, USING ALTERNATE METHODS AT AN EXTERNAL LAB: HBS ANTIBODIES: <2 (NEGATIVE) - THIS RESULT WAS COMMUNICATED TO THE DOCTOR, AS CONSISTENT WITH CLINICAL EXPECTATION. HBS ANTIGENS: POSITIVE. ON (B)(6) 2023, A RETAINED SAMPLE (DRAWN (B)(6) 2023) FROM THE SAME PATIENT WAS SUBJECTED TO ADDITIONAL TESTING: ATELLICA AHBS2: 40.94 MIU/ML (POSITIVE) PCR VIREMIA: NEGATIVE IT IS NOTED THAT THE SAME PATIENT HAD TESTED NEGATIVE FOR AHBS2 IN 2015, AND THAT THE PATIENT HAD BEEN HBCT AND HBSII POSITIVE SINCE 2013. THE ATELLICA IM TNIH INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER LIMITATIONS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS". SIEMENS IS INVESTIGATING. NOTE: THE DISCORDANT OBSERVATION OF (B)(6) 2023 IS REPORTED IN MDR 1219913-2023-00039.

    Additional Manufacturer Narrative · 0

    MDR 1219913-2023-00040 WAS INITIALLY SUBMITTED ON 2023-02-27. UPDATE, 2023-04-27: SIEMENS HAS CONCLUDED THE INVESTIGATION. A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF POSITIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULTS FOR ONE PATIENT WHICH WERE DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. SIEMENS REQUESTED THE AFFECTED SAMPLE FOR ADDITIONAL TESTING, BUT THERE WAS INSUFFICIENT VOLUME AVAILABLE. IT WAS NOTED THAT THE PATIENT HAS A HISTORY OF CHRONIC HEPATITIS WITH ONGOING ANTIVIRAL TREATMENTS. QUALITY CONTROL (QC) PERFORMANCE WAS REVIEWED, WITH NO ISSUES NOTED. BASED ON THE OBSERVED REPLICATION OF ELEVATED RESULTS, SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS OR A SAMPLE-SPECIFIC INTERFERENT AS THE CAUSE OF THE REACTIVE TESTING. THE CLINICAL SENSITIVITY AND SPECIFICITY SECTION OF THE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) INSTRUCTIONS FOR USE (IFU) 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 FOR THIS ASSAY. THE ASSAY IS PERFORMING AS EXPECTED AND WITHIN SPECIFICATIONS. RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL AND REQUIRES NO FURTHER SUPPORT. NOTES: IN SECTION H6, THE CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSION HAVE BEEN UPDATED. MDR 1219913-2023-00039 SUPPLEMENTAL 1 HAS BEEN FILED IN ASSOCIATION WITH THE RELATED OBSERVATION OF 2023-02-13.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED OBSERVATION OF A POSITIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT FOR ONE PATIENT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE NEGATIVE (ALTERNATE-METHOD) RESULT WAS ACCEPTED AS CONSISTENT WITH PATIENT CLINICAL INDICATIONS. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED DISCORDANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798862 ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) AHBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 155 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 Female