BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG REAGENT KIT

    MDR report key: 23166184 · Received September 29, 2025

    Report

    Report Number
    3008344661-2025-00135
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 20, 2025
    Report Date
    November 17, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740160104
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE NEGATIVE ALINITY I HBSAG RESULTS INCLUDED A REVIEW OF DATA AND INFORMATION PROVIDED BY THE CUSTOMER, SEARCH FOR SIMILAR COMPLAINTS, TICKET TRENDING REVIEW, LABELING REVIEW, DEVICE HISTORY RECORD REVIEW, AND IN HOUSE TESTING. DATA WAS REVIEWED AND SUPPORT THE COMPLAINT ISSUE. A SEARCH FOR SIMILAR COMPLAINTS IDENTIFIED AN INCREASE IN COMPLAINT ACTIVITY FOR LOT 72553FZ01, HOWEVER, NO INCREASE IN COMPLAINT ACTIVITY WAS IDENTIFIED FOR LIST NUMBER 08P08. DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE LOT NUMBER AND COMPLAINT ISSUE. IN HOUSE CLINICAL SENSITIVITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF LOT 72553FZ01 STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESSES THE CURRENT ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WITH THE ALINITY I HBSAG ASSAY FOR LOT 72553FZ01 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 08P08 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 04P53, ARCHITECT HBSAG, WITH PMA NUMBER P110029. COMPLETE ENTRY FOR SECTION A1 - PATIENT IDENTIFIER: (B)(6). 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 NEGATIVE ALINITY I HBSAG RESULT FOR ONE PATIENT WITH A HISTORY OF POSITIVE HEPATITIS B. THE NEGATIVE RESULT WAS NOT REPORTED OUT. THE SAMPLE WAS REPEATED WITH POSITIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED (< 0.05 IU/ML NONREACTIVE = 0.05 IU/ML REACTIVE): SID (B)(6) INITIAL HBSAG RESULT = 0.01 IU/ML REPEATED AFTER CENTRIFUGATION = 0.13 IU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED A FALSE NEGATIVE ALINITY I HBSAG RESULT FOR ONE PATIENT WITH A HISTORY OF POSITIVE HEPATITIS B. THE NEGATIVE RESULT WAS NOT REPORTED OUT. THE SAMPLE WAS REPEATED WITH POSITIVE RESULTS. THE FOLLOWING DATA WAS PROVIDED (0.05 IU/ML NONREACTIVE = 0.05 IU/ML REACTIVE): SID (B)(6) INITIAL HBSAG RESULT = 0.01 IU/ML REPEATED AFTER CENTRIFUGATION = 0.13 IU/ML NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297216 ALINITY I HBSAG REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 72553FZ01 00380740160104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALNTY I PROCESSING MODU, 03R65-01, (B)(6).| ALNTY I PROCESSING MODU, 03R65-01, (B)(6).