BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 25253697 · Received May 22, 2026

    Report

    Report Number
    3002809144-2026-00134
    Event Type
    Malfunction
    Date Received
    May 22, 2026
    Date of Event
    May 13, 2026
    Report Date
    May 22, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740162580
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P84, PMA P080023.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ALINITY I ANTI-HBC RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR A 50-YEAR-OLD MALE PATIENT WITH CHRONIC HEPATITIS B WHO IS RECEIVING ANTIVIRAL TREATMENT. INITIAL ANTI-HBC RESULT = 0.72 S/CO, INITIAL HBEAG RESULT = 2.95 S/CO (REFERENCE RANGE <1.0 S/CO) WITH THE OTHER HEPATITIS MARKERS NEGATIVE. REPEAT ANTI-HBC RESULT ON AUTOBIO WAS POSITIVE AND HBEAG = 4.41 S/CO (REFERENCE RANGE: BOTH HBEAG AND ANTI-HBC <1.0 S/CO). HBV DNA TEST WAS NEGATIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348107 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 83173BE01 00380740162580

    Patients

    Seq Age Sex Outcome Treatment
    1