BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 7123893 · Received December 15, 2017

    Report

    Report Number
    3008344661-2017-00105
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    November 3, 2017
    Report Date
    March 12, 2018
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PATIENT SAMPLE WAS RECEIVED FOR INVESTIGATION. THE RETURN PATIENT SAMPLE (B)(6) WAS TESTED USING AN IN-HOUSE RETAINED KIT OF ARCHITECT (B)(6) QUALITATIVE II, LIST 2G22-25 LOT 77259FN00 WHICH WAS STORED AT THE RECOMMENDED STORAGE CONDITION. THE PATIENT SAMPLE RESULT OF (B)(6) MATCHED THE NATURE OF THE CUSTOMER'S COMPLAINT (B)(6). THE RETURN PATIENT SAMPLE ALSO GENERATED A (B)(6) RESULT WHEN TESTED ON THE ALINITY I PLATFORM. TESTING OF PANELS WHICH MIMIC PATIENT SAMPLES USING IN-HOUSE RETAINED KITS OF LOT 77259FN00 WAS PERFORMED; ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. A REVIEW OF THE PRODUCT QUALITY HISTORY ASSOCIATED WITH THE ARCHITECT (B)(6) QUALITATIVE II REAGENT LOT 77259FN00 DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE ARCHITECT (B)(6) QUALITATIVE II REAGENT PACKAGE INSERT WAS REVIEWED AND IT WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. ABBOTT MEDICAL AFFAIRS HAVE PREVIOUSLY COMMENTED ON SAMPLES WHICH ARE (B)(6) BUT (B)(6) SURFACE ANTIGEN (B)(6) IS UNDETECTABLE: A GROUP OF PATIENTS WITH CHRONIC (B)(6) INFECTION HAS BEEN IDENTIFIED BY (B)(6), MOLECULAR TESTING FOR (B)(6) DNA. MEMBERS OF THIS GROUP ARE OFTEN REFERRED TO AS HAVING OCCULT (B)(6) VIRUS (B)(6) INFECTION WHICH IS DIAGNOSED WHEN AN HBV DNA TEST IS (B)(6) BUT (B)(6) SURFACE ANTIGEN (B)(6) IS UNDETECTABLE. OCCULT (B)(6) INFECTION (OBI) OCCURS IN A NUMBER OF CLINICAL SETTINGS AND MAY REPRESENT: ACUTE INFECTION IN THE WINDOW PERIOD, (B)(6) TAILEND OF CHRONIC (B)(6) INFECTION, PERSISTENCE OF REPLICATION AT LOW LEVEL AFTER RECOVERY IN THE PRESENCE OF (B)(6), OR (IV) OCCURRENCE OF AN ESCAPE MUTANT IN VACCINATED OR UNVACCINATED INDIVIDUALS NOT DETECTED BY CURRENT (B)(6) ASSAYS H. W. REESINK ET AL. OCCULT (B)(6) INFECTION IN BLOOD DONORS. VOX SANGUINIS (2008) 94 , 153-166 MICHAEL TORBENSON AND DAVID L THOMAS. OCCULT HEPATITIS B. LANCET INFECT DIS 2002; 2: 479-486 BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE ARCHITECT (B)(6) QUALITATIVE II ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2G22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L80 AND 4P53. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SUSPECTED (B)(6) ARCHITECT (B)(6) RESULTS WERE GENERATED ON A DONOR. A DONOR SAMPLE TESTED (B)(6) FOR (B)(6) WITH NAT TESTING ON (B)(6) 2017. ARCHITECT HBSAG QUALITATIVE II TESTING WAS PERFORMED AND WAS (B)(6). A NEW SAMPLE WAS DRAWN AND TESTED ON (B)(6) 2017 WITH THE SAME RESULTS FOR BOTH TECHNIQUES. A PREVIOUS SAMPLE FROM THE DONOR WAS (B)(6) FOR (B)(6) AND THE NEW SAMPLES WERE ALSO (B)(6). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902468 ARCHITECT HBSAG QUALITATIVE II HBSAG KSJ ABBOTT IRELAND 77259FN00

    Patients

    Seq Age Sex Outcome Treatment
    1