BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT

    MDR report key: 22097731 · Received May 28, 2025

    Report

    Report Number
    3008344661-2025-00077
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 12, 2025
    Report Date
    August 1, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740160609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 01R64-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01R64-21/31, WITH 510K/PMA/BLA NUMBER P210003.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION 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. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. DATA AND INFORMATION PROVIDED BY THE CUSTOMER WERE REVIEWED AND SUPPORT THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE. REVIEW OF TRACKING AND TRENDING FOR THE DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ALINITY I HBSAG NEXT QUALITATIVE REAGENT AND COMPLAINT LOT RELATED TO THE COMPLAINT ISSUE. IN-HOUSE PERFORMANCE TESTING WAS COMPLETED ON THE COMPLAINT LOT, WHICH CONCLUDED ACCEPTANCE CRITERIA WAS MET, AND THE PRODUCT IS PERFORMING AS EXPECTED. DEVICE HISTORY REVIEW DID NOT IDENTIFY ANY ISSUES WITH THE COMPLAINT LOT. LABELING WAS REVIEWED AND WAS FOUND TO ADDRESS THE CUSTOMER REPORTED ISSUE. BASED ON THE INFORMATION WITHIN THE COMPLAINT RECORD, THE DEVICE MET PERFORMANCE SPECIFICATIONS AND PERFORMED AS INTENDED AT THE CUSTOMER SITE, THEREFORE THERE IS NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT LOT 65476FZ00 WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I HBSAG NEXT QUALITATIVE RESULTS FOR ONE PATIENT. THE PATIENT WAS REACTIVE BY ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED (= 1.00 REACTIVE): SID (B)(6) PROCESSED ON (B)(6) 2025 ALINITY I HBSAG NEXT RESULT = 0.32 S/CO REPEAT RESULTS = 0.39 S/CO AND 0.33 S/CO. SAME PATIENT EDTA TUBE = 0.7 S/CO. SIEMEN RESULT = 99 COI (= 1.00 IS REACTIVE). PATIENT¿S CLINICAL HISTORY IS NON-REACTIVE WITH HBSAG THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSE NON-REACTIVE ALINITY I HBSAG NEXT QUALITATIVE RESULTS FOR ONE PATIENT. THE PATIENT WAS REACTIVE BY ANOTHER METHOD. THE FOLLOWING DATA WAS PROVIDED(= 1.00 REACTIVE): SID (B)(6) PROCESSED ON (B)(6) 2025 ALINITY I HBSAG NEXT RESULT = 0.32 S/CO REPEAT RESULTS = 0.39 S/CO AND 0.33 S/CO SAME PATIENT EDTA TUBE = 0.7 S/CO. SIEMEN RESULT = 99 COI (= 1.00 IS REACTIVE) PATIENT¿S CLINICAL HISTORY IS NON-REACTIVE WITH HBSAG THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432957 ALINITY I HBSAG NEXT QUALITATIVE REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 65476FZ00 00380740160609

    Patients

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