BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18753966 · Received February 21, 2024

    Report

    Report Number
    1219913-2024-00036
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    January 26, 2024
    Report Date
    February 11, 2025
    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
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER OBTAINED A DISCORDANT REACTIVE (POSITIVE) RESULT WITH ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) THAT WAS NON-REACTIVE (NEGATIVE) WHEN THE SAME SAMPLE WAS TESTED ON AN ALTERNATE METHOD. THE CUSTOMER INDICATED THAT THE PHYSICIAN HAD INITIALLY EXPECTED THE HEPATITIS B ANTIBODY TO BE NOT DETECTED BECAUSE THE PATIENT HAD A STRONG REACTIVE RESULT FOR HEPATITIS B ANTIGEN (RESULT WAS NOT PROVIDED). THE LIMITATIONS SECTION OF THE ASSAY INSTRUCTIONS FOR USE (IFU) STATES: "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." THE INTERPRETATION OF RESULTS SECTION OF THE IFU STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING THIS EVENT.

    Additional Manufacturer Narrative · 0

    SIEMENS INVESTIGATED AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVATION OF A DISCORDANT REACTIVE (POSITIVE) RESULT WITH ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) LOT 163 THAT WAS NON-REACTIVE (NEGATIVE) WHEN THE SAME SAMPLE WAS TESTED ON AN ALTERNATE METHOD. QUALITY CONTROL (QC) WAS WITHIN ACCEPTABLE RANGES AND NO ISSUES WERE REPORTED WITH OTHER PATIENT SAMPLES. THE CUSTOMER TREATED THE PATIENT SAMPLE WITH HETEROPHILIC BLOCKING TUBE (HBT) AND RESULTS WERE LOWER AS EXPECTED. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS A SAMPLE SPECIFIC INTERFERENCE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE IS RESOLVED BY ROUTINE TROUBLESHOOTING. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    A CUSTOMER OBTAINED A DISCORDANT REACTIVE (POSITIVE) RESULT WITH ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) THAT WAS NON-REACTIVE (NEGATIVE) WHEN THE SAME SAMPLE WAS TESTED ON AN ALTERNATE METHOD. THE INITIAL REACTIVE RESULT WAS REPORTED AND QUESTIONED BY THE PHYSICIAN. A CORRECTED REPORT WAS ISSUED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT REACTIVE AHBS2 RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415999 ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A UNKNOWN 00630414597836

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown