BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 24512963 · Received March 4, 2026

    Report

    Report Number
    3008344661-2026-00047
    Event Type
    Malfunction
    Date Received
    March 4, 2026
    Date of Event
    February 11, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740138165
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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 07P89 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P88, ANTI-HBS, WITH PMA NUMBER P050051.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I ANTI-HBS RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 47-YEAR-OLD FEMALE PATIENT. THE SAMPLE WAS REPEATED, AND A LOWER RESULT WAS OBTAINED. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6). (B)(6) 2026 ALINITY I ANTI-HBS RESULT = 595.44 MIU/ML, REPEAT RESULT = 0.59 MIU/ML. 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
    567928 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 76183FZ00 00380740138165

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)