BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 10044111 · Received May 11, 2020

    Report

    Report Number
    3008344661-2020-00035
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 22, 2020
    Report Date
    June 19, 2020
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT CODE FROM INCORRECT KSJ TO THE CORRECT LOM. THE COMPLAINT INVESTIGATION FOR POTENTIAL FALSE NEGATIVE HBSAG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND REVIEW OF COMPLAINT TEXT, INSTRUMENT RESULT LOGS, TRENDING DATA, LABELING, AND DEVICE HISTORY RECORDS. IN HOUSE SENSITIVITY TESTING OF PANELS WHICH MIMIC PATIENT SAMPLES WAS COMPLETED USING A RETAINED KIT OF LOT 06418FN00. ALL SPECIFICATIONS WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. TRENDING REVIEW DETERMINED NO TRENDS FOR THE ISSUE FOR THE PRODUCT. DEVICE HISTORY RECORD REVIEW ON LOT 06418FN00 DID NOT SHOW ANY POTENTIAL 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 THE ARCHITECT HBSAG ASSAY, LOT NUMBER 06418FN00 WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION PATIENT IDENTIFIER = (B)(6). ALL AVAILABLE PATIENT INFORMATION HAS BEEN INCLUDED. NO ADDITIONAL PATIENT DETAILS ARE AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS EVENT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST 6C36, THAT HAS A SIMILAR US PRODUCT, LIST 4P53.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED (B)(6) ALINITY I HBSAG RESULTS FOR ONE PATIENT. THE CUSTOMER PROVIDED: SID (B)(6) HBSAG = ((B)(6)); HBSAB = ((B)(6)), HBEAG = ((B)(6)), HBEAB = ((B)(6)), HBCAB = ((B)(6)); (B)(6)-DNA = ((B)(6)). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507458 ARCHITECT HBSAG HBSAG LOM ABBOTT IRELAND DIAGNOSTICS DIVISION 06418FN00

    Patients

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