BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 24895474 · Received April 16, 2026

    Report

    Report Number
    3002809144-2026-00093
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    April 8, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ABBOTT GMBH
    Product Code
    LOM
    UDI-DI
    00380740162573
    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. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P87 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P84, WITH 510K/PMA/BLA NUMBER P080023.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HBC II RESULT GENERATED ON THE ALINITY I PROCESSING MODULE FOR A 72-YEAR-OLD FEMALE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE 1: INITIAL RESULT = 0.04 S/CO. REPEAT RESULTS = 5.28 AND 4.82 S/CO. REFERENCE RANGE FOR ANTI-HBC: < 1.00 S/CO NONREACTIVE, >/= 1.00 S/CO REACTIVE . THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955811 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 80152BE01 00380740162573

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female ALNTY I PROCESSING MODU, 03R65-01, (B)(6)