BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 9729539 · Received February 19, 2020

    Report

    Report Number
    3008344661-2020-00017
    Event Type
    Malfunction
    Date Received
    February 19, 2020
    Date of Event
    January 18, 2020
    Report Date
    April 30, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D2 PRODUCT CODE WAS CHANGED FROM KSJ TO LOM. THIS WAS NECESSARY TO CORRECT AN ERROR IN THE INITIAL REPORT. COMPLAINT TRENDING REPORT REVIEW FOR THE ARCHITECT HBSAG QUALITATIVE II ASSAY DETERMINED THAT THERE WERE NO TRENDS ASSOCIATED WITH THE COMPLAINT ISSUE. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. SINCE THE REAGENT LOT WAS NOT PROVIDED LOT SPECIFIC ANALYSIS COULD NOT BE PERFORMED. TO EVALUATE THE PERFORMANCE OF THE ARCHITECT HBSAG QUALITATIVE II ASSAY WORLDWIDE FIELD DATA WAS EVALUATED. THE MEDIAN PATIENT RESULT FOR ALL ON MARKET LOTS FOR SAMPLES WITHIN THE RANGE 0.8 TO 5.25 S/CO FALLS WITHIN ESTABLISHED BASELINES AND CONFIRMS NO SYSTEMIC ISSUE FOR THE PRODUCT. A REVIEW OF THE PRODUCT QUALITY HISTORY FOR THE ASSAY DID NOT IDENTIFY ISSUES ASSOCIATED WITH ISSUE. ADDITIONALLY, LABELLING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESSES THE CURRENT ISSUE. NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT HBSAG QUALITATIVE II ASSAY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT (B)(6) QUALITATIVE II, LIST 2G22, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, (B)(6), LIST NUMBER 4P53. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. SECTION A PATIENT INFORMATION: NO SPECIFIC PATIENT INFORMATION WAS PROVIDED. REFER TO RELATED MANUFACTURER REPORT NUMBERS 3002809144-2020-00132 FOR THE DEVICE EVALUATION OF THE ARCHITECT (B)(6) ASSAY AND 3002809144-2020-00131 FOR THE DEVICE EVALUATION OF THE ARCHITECT (B)(6) IGM ASSAY.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED FALSE NEGATIVE ARCHITECT (B)(6) RESULTS FOR ONE DONOR. THE CUSTOMER INDICATE THE SAMPLE GENERATED POSITIVE RESULTS FOR (B)(6) (258.05 MIU/ML) ASSAYS FROM ROCHE. NO IMPACT TO PATIENT/DONOR MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188954 ARCHITECT HBSAG QUALITATIVE II HBSAG LOM ABBOTT IRELAND DIAGNOSTICS DIVISION UNKNOWN

    Patients

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