BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I ANTI-HBS REAGENT KIT

    MDR report key: 22881688 · Received August 24, 2025

    Report

    Report Number
    3008344661-2025-00119
    Event Type
    Malfunction
    Date Received
    August 24, 2025
    Date of Event
    August 7, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740159900
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 7P89 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 7P88, AND 510K/PMA/BLA OF P050051. SECTION A PATIENT INFORMATION: NO PATIENT INFORMATION WAS PROVIDED. SECTION E1 INITIAL REPORTER ESTABLISHMENT NAME: CHARACTER LIMIT EXCEEDED. COMPLETE INITIAL REPORTER ESTABLISHMENT NAME IS (B)(6) HOSPITAL. AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. THE TICKET SEARCH BY LOT INDICATES THAT THE REAGENT LOT PERFORMS AS EXPECTED FOR THIS PRODUCT. THE TICKET TRENDING REVIEW OF COMPLAINT DATA FOR THE COMPLAINT LIST NUMBER DOES NOT IDENTIFY ANY INCREASE IN COMPLAINT ACTIVITY. THE LABELING REVIEW CONCLUDES THAT THE ISSUE IS ADEQUATELY ADDRESSED. A DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY POTENTIAL NON-CONFORMANCES, NON-CONFORMANCES AND DEVIATIONS ASSOCIATED WITH THE COMPLAINT LOT NUMBER AND COMPLAINT ISSUE. FIELD DATA REVIEW SHOWED COMPLAINT LOT IS WITHIN ESTABLISHED LIMITS AND IS PERFORMING ACCEPTABLY ON MARKET. A LITERATURE REVIEW SHOWED THAT ACCORDING TO AN ARTICLE BY COLSON, PHILIPPE ET. AL., ON THE CLINICAL AND VIROLOGICAL SIGNIFICANCE OF THE CO-EXISTENCE OF HBSAG AND ANTI-HBS ANTIBODIES IN HEPATITIS B CHRONIC CARRIERS - "PREVALENCE OF ANTI-HBS CO-EXISTENCE WAS 3.1% IN OUR POPULATION OF HBSAG-POSITIVE PATIENTS." BASED ON THIS INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY WAS IDENTIFIED WITH THE ALINITY I ANTI-HBS REAGENT LOT IDENTIFIED IN THIS COMPLAINT.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED THE ELEVATED ALINITY I ANTI-HBS RESULT. FOR A HEPATITIS B PATIENT, THE CUSTOMER STATED THE HBSAG AND ANTI-HBS RESULTS WERE SIMULTANEOUSLY POSITIVE, AND HAD QUESTIONS ABOUT THE ANTI-HBS RESULT. THE PATIENT¿S RESULTS WERE AS FOLLOWS: HBSAG: >250, REFERENCE RANGE: <0.05. HBSAB: 139.621, REFERENCE RANGE: < 10. HBEAG: 0.373, REFERENCE RANGE: <1. HBEAB: 0.02, REFERENCE RANGE: >1. HBCAB: 8.048, REFERENCE RANGE: <1. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER QUESTIONED THE ELEVATED ALINITY I ANTI-HBS RESULT. FOR A HEPATITIS B PATIENT, THE CUSTOMER STATED THE HBSAG AND ANTI-HBS RESULTS WERE SIMULTANEOUSLY POSITIVE, AND HAD QUESTIONS ABOUT THE ANTI-HBS RESULT. THE PATIENT¿S RESULTS WERE AS FOLLOWS: HBSAG: >250, REFERENCE RANGE: <0.05. HBSAB: 139.621, REFERENCE RANGE: < 10. HBEAG: 0.373, REFERENCE RANGE: <1. HBEAB: 0.02, REFERENCE RANGE: >1. HBCAB: 8.048, REFERENCE RANGE: <1. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291856 ALINITY I ANTI-HBS REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 68373FZ01 00380740159900

    Patients

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