BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINITY I HBSAG NEXT CONFIRMATORY REAGENT KIT

    MDR report key: 21989411 · Received May 8, 2025

    Report

    Report Number
    3008344661-2025-00066
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    April 16, 2025
    Report Date
    July 9, 2025
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    UDI-DI
    00380740161279
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    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 A1 - PATIENT IDENTIFIER COMPLETE ENTRY = (B)(6) ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. SECTION E1 - PHONE COMPLETE ENTRY = (B)(6). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 01R65-22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 01R65-21, AND A PMA NUMBER OF P210003.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION FOR FALSE REACTIVE ALINITY I HBSAG NEXT QUALITATIVE AND CONFIRMED POSITIVE ALINITY I HBSAG QUALITATIVE II CONFIRMATORY RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. SPECIFICITY TESTING WAS PERFORMED USING AN IN-HOUSE RETAINED KIT OF ALINITY I HBSAG NEXT QUALITATIVE, LOT 67085FZ00, AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY, LOT 69143FZ00, STORED AT THE RECOMMENDED STORAGE CONDITION. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOTS ARE PERFORMING ACCEPTABLY. A REVIEW OF TRACKING AND TRENDING FOR THE PRODUCTS AND THE LIKELY CAUSE LOTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY. DEVICE HISTORY RECORD REVIEW OF THE LOTS DID NOT SHOW ANY NON-CONFORMANCES OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF ALINITY I HBSAG NEXT QUALITATIVE, LOT 67085FZ00, AND ALINITY I HBSAG QUALITATIVE II CONFIRMATORY, LOT 69143FZ00, WAS IDENTIFIED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HBSAG NEXT QUALITATIVE AND ALINITY I HBSAG NEXT CONFIRMATORY RESULTS FOR ONE 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 6.16, REPEAT RESULTS WERE 8.60 AND 0.17 S/CO. THE SAMPLE WAS REPEATED ON AN ARCHITECT ANALYZER AND THE RESULT WAS 0.33 S/CO, WHICH IS NONREACTIVE. THE SAMPLE WAS TESTED WITH THE HBSAGNX CONFIRMATORY ASSAY, AND THE RESULTS WERE C2 WAS 8.60 S/CO, C1 WAS 0.63 S/CO, %N WAS 96%. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE REACTIVE ALINITY I HBSAG NEXT QUALITATIVE AND ALINITY I HBSAG NEXT CONFIRMATORY RESULTS FOR ONE 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 6.16, REPEAT RESULTS WERE 8.60 AND 0.17 S/CO. THE SAMPLE WAS REPEATED ON AN ARCHITECT ANALYZER AND THE RESULT WAS 0.33 S/CO, WHICH IS NONREACTIVE. THE SAMPLE WAS TESTED WITH THE HBSAGNX CONFIRMATORY ASSAY, AND THE RESULTS WERE C2 WAS 8.60 S/CO, C1 WAS 0.63 S/CO, %N WAS 96%. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946270 ALINITY I HBSAG NEXT CONFIRMATORY REAGENT KIT TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM) LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 69143FZ00 00380740161279

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ALN HBSAG NXT QUAL 200T, 01R64-22, 67085FZ00| ALN HBSAG NXT QUAL 200T, 01R64-22, 67085FZ00| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)| ALNTY I PROCESSING MODU, 03R65-01, (B)(6)