BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG REAGENT KIT

    MDR report key: 16193563 · Received January 18, 2023

    Report

    Report Number
    3008344661-2023-00028
    Event Type
    Malfunction
    Date Received
    January 18, 2023
    Date of Event
    January 1, 2023
    Report Date
    March 14, 2023
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE TICKET SEARCH BY LOT COULD NOT BE PERFORMED SINCE THE LIKELY CAUSATIVE AGENT LOT NUMBER IS UNKNOWN. THERE ARE NO TRENDS FOR THE PRODUCT RELATED TO PATIENT RESULTS. NO CUSTOMER RETURNS WERE AVAILABLE FOR EVALUATION. THE OVERALL PERFORMANCE OF ARCHITECT HBSAG QUANTITATIVE REAGENTS IN THE FIELD WAS REVIEWED USING DATA GATHERED VIA ABBOTTLINK FROM CUSTOMERS WORLDWIDE AND SUGGESTED THAT THE PERFORMANCE IS ACCEPTABLE. MANUFACTURING DOCUMENTATION FOR THE LIKELY CAUSE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE COMPLAINT ISSUE. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. NO SYSTEMIC ISSUE OR PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53.

    Description of Event or Problem · 0

    A JOURNAL ARTICLE BY YING YAN, HUIZHEN SUN, LE CHANG, HUIMIN JI, XINYI JIANG, SHI SONG, YINGZI XIAO, KAIHAO FENG, ABUDULIMUTAILIPU NUERMAIMAITI, ZHUOQUN LU AND LUNAN WANG, ¿CIRCULATING IMMUNE COMPLEXES AND MUTATIONS OF HBSAG ARE ASSOCIATED WITH THE UNDETECTABLE HBSAG IN ANTI-HBS AND HBEAG POSITIVE OCCULT HEPATITIS B VIRUS INFECTION¿, FRONTIERS IN MICROBIOLOGY, 29 NOVEMBER 2022. THE STUDY NOTED FALSE NONREACTIVE ARCHITECT HBSAG RESULTS ON 1,487 DONOR SAMPLES THAT WERE POSITIVE BY COBAS HBV DNA. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820898 ARCHITECT HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ARC I2000SR INST, 03M74-02, 116UNKNOWND14| ARC I2000SR INST, 03M74-02, 116UNKNOWND14