BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18852009 · Received March 6, 2024

    Report

    Report Number
    1219913-2024-00060
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 12, 2024
    Report Date
    April 22, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    PMA / PMN Number
    P100039-S005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER FROM OUTSIDE THE UNITED SATES REPORTED OBSERVATION OF A REACTIVE (POSITIVE) ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO ALTERNATE-METHOD TESTING. THE ATELLICA IM AHBS2 INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    MDR 1219913-2024-00060 WAS INITIALLY SUBMITTED ON 06-MAR-24. UPDATE, APRIL 2024: SIEMENS HAS CONCLUDED THE INVESTIGATION. A CUSTOMER FROM OUTSIDE THE UNITED STATES REPORTED OBSERVATION OF A REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL INDICATIONS AND ALTERNATE-METHOD TESTING. QUALITY CONTROL (QC) RESULTS WERE WITHIN ACCEPTABLE RANGES, AND NO ISSUES WERE OBSERVED WITH ANY OTHER SAMPLES. ASSAY CALIBRATION DATA DID NOT INDICATE ANY ISSUES. ON THE BASIS OF THIS INFORMATION, GENERAL REAGENT ISSUES WERE RULED OUT AS A LIKELY CAUSE. SERVICE WAS DISPATCHED TO REVIEW INSTRUMENT PERFORMANCE AND PERFORM COMPREHENSIVE INSTRUMENT MAINTENANCE. THERE WERE NO INSTRUMENT OBSERVATIONS TO EXPLAIN THE IDENTIFIED RESULT DISCORDANCE. THERE IS NOT SUFFICIENT SAMPLE MATERIAL AVAILABLE TO PERMIT ADDITIONAL TESTING. ALTHOUGH A SPECIFIC CAUSE WAS NOT IDENTIFIED, BASED ON THE AVAILABLE INFORMATION, THE DISCORDANT RESULT MAY BE ATTRIBUTABLE TO A SAMPLE-SPECIFIC INTERFERENT. IT IS NOTED THAT OTHER HEPATITIS ASSAYS ALSO PRODUCED REACTIVE RESULTS WHICH WERE INCONSISTENT WITH THE PATIENT¿S CLINICAL PRESENTATION. THE ASSAY¿S INSTRUCTIONS FOR USE (IFU) ADVISES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: ¿RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS.¿ NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL, AND NO FURTHER ACTION IS REQUIRED. NOTE: IN SECTION H6, CODES FOR INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS OBSERVATION OF A REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) RESULT WHICH WAS DISCORDANT RELATIVE TO CLINICAL INDICATIONS AND ALTERNATE-METHOD TESTING. AHBS2 KIT LOT 164 WAS IN USE AT THE TIME. THE REACTIVE ATELLICA IM AHBS2 RESULT CONFLICTS WITH A NONREACTIVE/NEGATIVE AHBS RESULT FROM AN ALTERNATE METHOD TEST. ADDITIONALLY, ELEVATED REACTIVE HBSII (HEPATITIS B SURFACE ANTIGEN) RESULTS ARE SAID TO INDICATE THAT THE REACTIVE AHBS2 RESULT IS FALSELY POSITIVE. IT IS INDICATED THAT INTERFERENCE BY HETEROPHILIC ANTIBODIES HAS BEEN EXCLUDED. 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
    196549 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 164 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female