BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 21076030 · Received January 5, 2025

    Report

    Report Number
    3008344661-2025-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2025
    Date of Event
    December 9, 2024
    Report Date
    January 23, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740130206
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION, THE SUSPECT MEDICAL DEVICE WAS CHANGED FROM ALINITY I HBSAG REAGENT KIT, LIST NUMBER 08P08-52, ABBOTT IRELAND DIAGNOSTICS DIVISION, SLIGO TO ALINITY I HBSAG QUALITATIVE II REAGENT KIT, LIST NUMBER 08P10-22, ABBOTT IRELAND DIAGNOSTICS DIVISION, SLIGO. MDR NUMBER 3008344661-2025-00010 HAS BEEN SUBMITTED AND ALL FURTHER INFORMATION WILL BE DOCUMENTED UNDER THAT MDR NUMBER.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 8P08 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 4P53, WITH 510K/PMA/BLA NUMBER P110029. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I HBSAG FOR ONE PATIENT. THE CUSTOMER REPORTED THAT THE CURRENT RESULT WAS NOT CONSISTENT WITH THE HISTORICAL RESULT. THE RESULT IN 2023 WAS CONFIRMED WITH THE NEUTRALIZING CONFIRMATORY ASSAY AND THE RESULT IN 2024 WAS NOT CONFIRMED WITH THE NEUTRALIZING CONFIRMATORY ASSAY. THE 2024 SAMPLE ALSO WAS NON-REACTIVE FOR ANTI-HBS AND ANTI-HBC. THERE WERE NO SPECIFIC PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE REACTIVE ALINITY I HBSAG FOR ONE PATIENT. THE CUSTOMER REPORTED THAT THE CURRENT RESULT WAS NOT CONSISTENT WITH THE HISTORICAL RESULT. THE RESULT IN 2023 WAS CONFIRMED WITH THE NEUTRALIZING CONFIRMATORY ASSAY AND THE RESULT IN 2024 WAS NOT CONFIRMED WITH THE NEUTRALIZING CONFIRMATORY ASSAY. THE 2024 SAMPLE ALSO WAS NON-REACTIVE FOR ANTI-HBS AND ANTI-HBC. THERE WERE NO SPECIFIC PATIENT RESULTS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351118 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 00380740130206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I HBS AG QUAL CON, 08P11-22, UNKNOWN| ALNTY I HBS AG QUAL CON, 08P11-22, UNKNOWN| ALNTY I PROCESSING MODU, 03R65-01, AI24007| ALNTY I PROCESSING MODU, 03R65-01, AI24007