BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 25070092 · Received May 4, 2026

    Report

    Report Number
    3008344661-2026-00069
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 4, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. 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 REPORTED FALSELY ELEVATED ALINITY I ANTI-HBS RESULTS GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 38-YEAR-OLD FEMALE PATIENT. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN VACCINATED AGAINST HEPATITIS B AND HAS NO HISTORY OF HEPATITIS B. THE FOLLOWING RESULTS WERE PROVIDED: SID 39: ALINITY I ANTI-HBS RESULT = 315.63, 324.96, 332.39 MIU/ML. HBV DNA = NEGATIVE. PER THE ALINITY I ANTI-HBS PACKAGE INSERT, INTERPRETATION OF RESULTS SECTION, AN ANTI-HBS CONCENTRATION = 10 MIU/ML IS REGARDED AS BEING PROTECTIVE AGAINST HEPATITIS B VIRAL INFECTION. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471056 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 77069FZ00 00380740159900

    Patients

    Seq Age Sex Outcome Treatment
    1