BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 25183686 · Received May 15, 2026

    Report

    Report Number
    3002809144-2026-00124
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 15, 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

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 07P87-74 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 07P84, WITH 510K/PMA/BLA NUMBER P080023. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A FALSE NONREACTIVE ALINITY I ANTI-HBC II RESULT GENERATED BY THE ALINITY I PROCESSING MODULE FOR A 49-YEAR-OLD FEMALE PATIENT DIAGNOSED WITH RECTAL CANCER. THIS RESULT WAS INCONSISTENT WITH THE PATIENT¿S HISTORICAL ANTI-HBC RESULTS. UPON RETESTING, THE SAMPLE YIELDED REACTIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, = 1.00 S/CO IS REACTIVE): (B)(6). INITIAL RESULT = 0.59 S/CO (NONREACTIVE), REPEAT RESULT = 6.81 S/CO AND 7.90 S/CO; PAST ANTI-HBC RESULTS: POSITIVE; NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422897 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 83171BE01 00380740162573

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female ALNTY I PROCESSING MODU, 03R65-01, AI24748.