BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II REAGENT KIT

    MDR report key: 2972212 · Received February 21, 2013

    Report

    Report Number
    3008344661-2013-00009
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 31, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 02G22 THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE US, LIST NUMBER 01L80 AND 04P53.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A BATCH RECORD REVIEW, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. SENSITIVITY TESTING PROTOCOLS, USING A RETURN SAMPLE AND INHOUSE PANELS, WERE EXECUTED USING LOT 19322LF00; TESTING MET THE ACCEPTANCE CRITERIA AND DETERMINED THE REAGENT IS PERFORMING ACCEPTABLY. THE BATCH RECORD REVIEW FOUND NO ISSUES. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY AND NO MALFUNCTION OF THE ARCHITECT HBSAG QUALITATIVE II ASSAY, LIST NUMBER 02G22, LOT 19322LF00 WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSE NEGATIVE (B)(6) RESULTS FOR ONE PATIENT WHILE USING THE ARCHITECT (B)(6) QUALITATIVE II ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: (B)(6. ) THE SPECIMEN GENERATED A (B)(6) RESULT AND WAS CONFIRMED WHEN TESTED WITH ANOTHER METHOD, SIEMENS CENTAUR. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76464 ARCHITECT HBSAG QUALITATIVE II REAGENT KIT KSJ ABBOTT IRELAND 19322LF00

    Patients

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