BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 8796586 · Received July 16, 2019

    Report

    Report Number
    3008344661-2019-00084
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    March 17, 2019
    Report Date
    August 27, 2019
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER SERVICE HAVE NOW CONFIRMED THAT ALL TEST RESULTS WERE GENERATED ON FUJI REBIO AND THE CUSTOMER NO LONGER HAS ANY CONCERNS WITH THE ARCHITECT ANTI-HBS PRODUCT. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF FIELD DATA, AND A REVIEW OF LABELING. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. NO RETURN PATIENT SAMPLE WAS AVAILABLE. HISTORICAL PERFORMANCE OF THE REAGENT LOT WAS EVALUATED USING WORLD WIDE DATA. THE PATIENT DATA WAS ANALYZED AND WITHIN EXPECTED LIMITS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT ANTI-HBS LN 7C18 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, AUSAB LN 1L82.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED A (B)(6) RESULTS ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED (MIU/ML) : (B)(6) 2018 (B)(6). (B)(6) 2019 (B)(6). (B)(6) 2019 (B)(6). (B)(6) 2019 (B)(6). PER THE PACKAGE INSERT, SPECIMENS WITH CONCENTRATION VALUES GREATER THAN OR EQUAL TO 10.00 ARE CONSIDERED REACTIVE BY THE CRITERIA OF ARCHITECT (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588710 ARCHITECT ANTI-HBS ANTI-HBS LOM ABBOTT IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR ANALYZER| ARCHITECT I2000SR ANALYZER| LN 03M74-01 SN (B)(4)| LN 03M74-01 SN (B)(4)