BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19442948 · Received June 1, 2024

    Report

    Report Number
    1219913-2024-00339
    Event Type
    Malfunction
    Date Received
    June 1, 2024
    Date of Event
    March 27, 2024
    Report Date
    September 27, 2024
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    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

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER REPORTED AN OBSERVATION OF A REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) PATIENT RESULT THAT WAS CONSIDERED DISCORDANT RELATIVE TO A NON-REACTIVE RESULT OBTAINED ON ANOTHER SAMPLE DRAWN FROM THE SAME PATIENT ON A LATER DATE. THE INTERPRETATION OF RESULTS SECTION OF THE ASSAY INSTRUCTIONS FOR USE (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.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR 1219913-2024-00339 ON 01-JUN-2024. SIEMENS COMPLETED INVESTIGATION FOR A CUSTOMER OBSERVATION OF A REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) LOT 166 PATIENT RESULT THAT WAS CONSIDERED DISCORDANT (REACTIVE) RELATIVE TO A NON-REACTIVE RESULT OBTAINED ON ANOTHER SAMPLE DRAWN FROM THE SAME PATIENT ON A LATER DATE. PER THE ATELLICA IM AHBS INSTRUCTION FOR USE (IFU) "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS'S INVESTIGATION INCLUDED AN ASSESSMENT OF THE FOLLOWING: REAGENT ISSUES WERE RULED OUT BASED ON REVIEW OF QUALITY CONTROL (QC), WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES. CALIBRATION DATA SHOWED VALID RESULTS. SIEMENS REQUESTED SAMPLE RETURN TO SIEMENS FOR ADDITIONAL TESTING, BUT VOLUME OF PATIENT SAMPLE WAS INSUFFICIENT. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE DISCORDANT RESULT IS CONSISTENT WITH A SAMPLE SPECIFIC INTERFERENT OF UNKNOWN ORIGIN DUE TO EXTREMELY HIGH INITIAL RESULTS AND THEN NON-REACTIVE RESULTS UPON REDRAW AT A LATER DATE. THE CUSTOMER IS OPERATIONAL, AND THE REPORTED ISSUE WAS 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

    THE CUSTOMER OBTAINED A REACTIVE ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2) LOT 166 PATIENT RESULT THAT WAS CONSIDERED DISCORDANT RELATIVE TO A NON-REACTIVE RESULT OBTAINED ON ANOTHER SAMPLE DRAWN FROM THE SAME PATIENT ON A LATER DATE. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN BUT WAS NOT QUESTIONED. THERE ARE NO ALLEGATIONS OF PATIENT OR USER INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2106443 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 166

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown