BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 24595695 · Received March 13, 2026

    Report

    Report Number
    3008344661-2026-00055
    Event Type
    Malfunction
    Date Received
    March 13, 2026
    Date of Event
    March 4, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159894
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P89 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P88, WITH 510K/PMA/BLA NUMBER P050051.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I ANTI-HBS FOR A 56-YEAR-OLD MALE DIAGNOSED WITH HEPATITIS B. THE FOLLOWING RESULTS WERE PROVIDED: SID (B)(6), INITIAL ANTI-HBS= 282.7 (REFERENCE RANGE <10). ADDITIONAL RESULTS PROVIDED: INITIAL HBSAG RESULT= 29.25 (REFERENCE RANGE <0.05); INITIAL HBEAG RESULT= 2.52 (REFERENCE RANGE <1); INITIAL ANTI-HBE= 1.31 (REFERENCE RANGE >1); INITIAL ANTI-HBC= 7.71 (REFERENCE RANGE <1). THE PATIENT'S PREVIOUS TEST RESULT FOR ANTI-HBS= 16.74. ADDITIONAL LAB RESULT PROVIDED: HBSAG RESULT= 412.98 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415903 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 76183FZ01 00380740159894

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male ALINI HBSAG QND 200T CN, 08P08-75, (B)(6) | ALNTY I PROCESSING MODU, 03R65-01, (B)(6)