BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBC II REAGENT KIT

    MDR report key: 24746058 · Received March 31, 2026

    Report

    Report Number
    3002809144-2026-00078
    Event Type
    Malfunction
    Date Received
    March 31, 2026
    Date of Event
    March 12, 2026
    Report Date
    May 21, 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. SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER: 07P87, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER: 07P84, AND A PMA NUMBER OF P080023.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NONREACTIVE ALINITY I ANTI-HBC II RESULT FOR A 54-YEAR-OLD MALE PATIENT. THE FOLLOWING DATA WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): SAMPLE ID: (B)(6) INITIAL RESULT WAS 0.62, REPEAT RESULTS WERE 4.27, 4.513, AND 4.355 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320405 ALINITY I ANTI-HBC II REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT GMBH 77227BE01 00380740162580

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male ALNTY I PROCESSING MODU, 03R65-01, (B)(6).