BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY

    MDR report key: 9825961 · Received March 12, 2020

    Report

    Report Number
    3008344661-2020-00026
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 28, 2020
    Report Date
    April 24, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SECTION D2: PRODUCT CODE WAS CHANGE FROM KSJ TO LOM. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, IN-HOUSE TESTING, REVIEW OF MANUFACTURING DOCUMENTS AND A REVIEW OF LABELING. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. THE CUSTOMER'S INSTRUMENT LOGS WERE REVIEWED, WHICH CONFIRMED THE INFORMATION PROVIDED BY THE CUSTOMER. REVIEW OF COMPLAINT TRENDING REPORTS DID NOT IDENTIFY ANY TRENDS FOR THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY. NORMAL COMPLAINT ACTIVITY WAS IDENTIFIED FOR REAGENT LOT 04338FN00. CLINICAL SENSITIVITY TESTING WAS PERFORMED USING A RETAINED KIT OF THE COMPAINT LOT. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. MANUFACTURING DOCUMENTATION FOR THE REAGENT LOT WAS REVIEWED AND DID NOT IDENTIFY ANY ISSUES. LABELING WAS REVIEWED AND SUFFICIENTLY ADDRESSES THE CUSTOMER'S ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: NO PATIENT SPECIFIC INFORMATION WAS PROVIDED. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY, LIST 2G23, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, HBSAG CONFIRMATORY, LIST NUMBER 4P54. 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 OBTAINED A (B)(6) ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY RESULT. SAMPLE ID (B)(6) GENERATED (B)(6) RESULTS ON ROCHE (B)(6). THE SAMPLE WAS TESTED NEAT ON THE ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY ASSAY AND GENERATED AN NOT CONFIRMED RESULT WITH C1 (B)(6) AND C2 (B)(6). THE SAMPLE WAS REPEATED NEAT GENERATING SIMILAR NOT CONFIRMED RESULTS OF C1 (B)(6) AND (B)(6). THE SAMPLE WAS DILUTED 1:500 AND GENERATED CONFIRMED (B)(6) RESULT WITH C1 (B)(6) AND %NEUTRALIZATION OF 99.97%. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287312 ARCHITECT HBSAG QUALITATIVE II CONFIRMATORY HBSAG CONFIRMATORY LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 04338FN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR, LIST 03M74-02,| ARCHITECT I2000SR, LIST 03M74-02,| SERIAL (B)(6) | SERIAL (B)(6)