BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21631600 · Received March 18, 2025

    Report

    Report Number
    1219913-2025-00054
    Event Type
    Malfunction
    Date Received
    March 18, 2025
    Date of Event
    February 10, 2025
    Report Date
    May 6, 2025
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    UDI-DI
    00630414597836
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER REPORTED AN OBSERVATION OF REPEAT REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2), LOT 174 PATIENT SAMPLE RESULTS WHICH WERE NOT IN ACCORDANCE WITH THE PATIENT HISTORY AND ALTERNATE METHOD TESTING. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES 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." SIEMENS IS INVESTIGATING. NOTE: THIS MDR ADDRESSES THE DISCORDANT RESULTS FOR SAMPLE ID (B)(6);(TEST DATE 2025-02-10) THE DISCORDANT RESULT FOR SAMPLE ID (B)(6); (TEST DATE 2025-02-14) IS BEING REPORTED IN SEPARATE MDR.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED INITIAL MDR 1219913-2025-00054 ON 15-MAR-2025. SIEMENS INVESTIGATED AN OUTSIDE OF THE UNITED STATES CUSTOMER REPORT OF REPEAT REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2), LOT 174 RESULTS ON A PATIENT WHICH WAS NOT IN ACCORDANCE WITH THE PATIENT HISTORY AND ALTERNATE METHOD TESTING. THE INVESTIGATION INCLUDED AN ASSESSMENT OF THE FOLLOWING WHICH RULED OUT PRODUCT ISSUES: -A REVIEW OF THE QUALITY CONTROL (QC) THAT WAS PROVIDED BY THE CUSTOMER. IT SHOWED RECOVERY WITHIN ACCEPTABLE RANGES. -NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. - CALIBRATION DATA WAS REVIEWED AND WAS FOUND TO BE VALID AND ACCEPTABLE. PER THE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) INSTRUCTIONS FOR USE (IFU 10995278_EN REV. 07_US AND IFU 10995277_EN REV. 07_OUS): "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." "ASSAY PERFORMANCE CHARACTERISTICS HAVE NOT BEEN ESTABLISHED FOR THE ATELLICA IM AHBS2 ASSAY USED IN CONJUNCTION WITH OTHER MANUFACTURERS' ASSAYS FOR SPECIFIC HBV SEROLOGICAL MARKERS. LABORATORIES ARE RESPONSIBLE FOR ESTABLISHING THEIR OWN PERFORMANCE CHARACTERISTICS." ADDITIONALLY, IFU 10995277_EN REV. 07_OUS LISTS 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. DISCORDANT RESULTS MAY OCCUR WHEN COMPARING PLATFORMS BASED ON THE SPECIFIC ASSAY DESIGN. THESE DIFFERENCES INCLUDE SENSITIVITY AND THE ABILITY TO DETECT BOTH WILD-TYPE AND MUTANT HBV STRAINS. OTHER ISSUES TO CONSIDER ARE THE PATIENT HISTORY OF VACCINATION, CLINICAL DIAGNOSIS AND INHERENT PATIENT SAMPLE INTERFERENCES. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT CANNOT BE DETERMINED, BUT APPEARS TO BE A PATIENT/SAMPLE SPECIFIC INTERFERANT. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING. MDR 1219913-2025-00054 SUPPLEMENTAL 1 IS FOR DISCORDANT RESULT FOR SAMPLE ID (B)(6) (TEST DATE (B)(6) 2025). MDR 1219913-2025-00053 SUPPLEMENTAL 1 IS FOR THE DISCORDANT RESULT FOR SAMPLE ID (B)(6) (TEST DATE (B)(6) 2025).

    Description of Event or Problem · 0

    THE CUSTOMER OBTAINED A REPEAT REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2), LOT 174 RESULT ON A PATIENT SAMPLE (ID: (B)(6) WHICH WAS NOT IN ACCORDANCE WITH THE PATIENT HISTORY AND ALTERNATE METHOD TESTING. THE DISCORDANT ATELLICA IM AHBS2 REACTIVE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538068 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 50062174 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female