BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 23605334 · Received November 20, 2025

    Report

    Report Number
    3008344661-2025-00162
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    November 15, 2025
    Report Date
    January 5, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740138066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SEE SECTION B5 DESCRIBE EVENT OR PROBLEM FOR COMPLETED PATIENT INFORMATION IN SECTION A PATIENT INFORMATION. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. 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 7C18 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L82, WITH 510K/PMA/BLA NUMBER P050051.

    Additional Manufacturer Narrative · 0

    SECTION D4 PRIMARY UDI NUMBER WAS UPDATED. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE LOT PERFORMS AS EXPECTED FOR THIS ISSUE AND PRODUCT. A REVIEW OF TRACKING AND TRENDING FOR THE ARCHITECT ANTI-HBS REAGENT DID NOT IDENTIFY ANY TRENDS REGARDING COMMONALTIES FOR THE LOT NUMBER AND COMPLAINT ISSUE. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. A REVIEW OF FIELD DATA SHOWS THE MEDIAN PATIENT RESULT FOR THE MASTER LOT FALLS WITHIN +/-2SD OF THE ESTABLISHED BASELINE, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY ON MARKET. LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED AND THE OVERALL SPECIFICITY WAS ESTIMATED TO BE 99.67%. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ARCHITECT ANTI-HBS ASSAY, LOT 73391FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT ANTI-HBS RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) (45 YEAR OLD, FEMALE PATIENT): INITIAL RESULT = 12.04 MIU/ML, REPEAT = 0.55 MIU/ML; SID (B)(6) (53 YEAR OLD, FEMALE PATIENT): INITIAL RESULT = 13.49 MIU/ML, REPEAT = 1.01 MIU/ML; SID (B)(6) 39 YEAR OLD, MALE PATIENT): INITIAL RESULT = 11.99 MIU/ML, REPEAT = 0.47 MIU/ML; SID (B)(6) (31 YEAR OLD, FEMALE PATIENT): INITIAL RESULT = 11.42 MIU/ML, REPEAT = 1.43 MIU/ML; SID (B)(6) (54 YEAR OLD, MALE PATIENT): INITIAL RESULT = 10.92 MIU/ML, REPEAT = 1.92 MIU/ML; SID (B)(6) (76 YEAR OLD, FEMALE PATIENT): INITIAL RESULT = 10.71 MIU/ML, REPEAT = 9.04 MIU/ML; SID (B)(6) (19 YEAR OLD, FEMALE PATIENT): INITIAL RESULT = 12.52 MIU/ML, REPEAT = 6.90 MIU/ML; NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT ANTI-HBS RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) (45-YEAR-OLD, FEMALE PATIENT): INITIAL RESULT = 12.04 MIU/ML, REPEAT = 0.55 MIU/ML. SID (B)(6) (53-YEAR-OLD, FEMALE PATIENT): INITIAL RESULT = 13.49 MIU/ML, REPEAT = 1.01 MIU/ML. SID (B)(6) 39-YEAR-OLD, MALE PATIENT): INITIAL RESULT = 11.99 MIU/ML, REPEAT = 0.47 MIU/ML. SID (B)(6) (31-YEAR-OLD, FEMALE PATIENT): INITIAL RESULT = 11.42 MIU/ML, REPEAT = 1.43 MIU/ML. SID (B)(6) (54-YEAR-OLD, MALE PATIENT): INITIAL RESULT = 10.92 MIU/ML, REPEAT = 1.92 MIU/ML. SID (B)(6) (76-YEAR-OLD, FEMALE PATIENT): INITIAL RESULT = 10.71 MIU/ML, REPEAT = 9.04 MIU/ML. SID (B)(6) (19-YEAR-OLD, FEMALE PATIENT): INITIAL RESULT = 12.52 MIU/ML, REPEAT = 6.90 MIU/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2662415 ARCHITECT ANTI-HBS TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 73391FZ00 00380740138066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ARC I2SR REFURB-SEKAT, 03M74-97, (B)(6)