BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBC II

    MDR report key: 1951357 · Received January 6, 2011

    Report

    Report Number
    2623532-2011-00001
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Report Date
    December 20, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, TESTING OF FILE KITS, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. RETAINED KITS OF ARCHITECT ANTI-HBC II REAGENT LOTS 92332HN00 AND 93464HN00 WERE CALIBRATED AND MET SPECIFICATIONS. ALL CONTROL VALUES MET SPECIFICATIONS AND WERE WITHIN RANGE. IN ADDITION, CLINICAL SENSITIVITY WAS EVALUATED FOR BOTH REAGENT LOTS WITH ACCEPTABLE RESULTS. TRACKING AND TRENDING DID NOT IDENTIFY ANY ADVERSE TREND RELATED TO THE CUSTOMER ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE EVALUATION NO PRODUCT DEFICIENCY FOR FALSE (B)(6) ARCHITECT (B)(4) RESULTS WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT ANTI-HBC II, LIST 8L44-25, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, ARCHITECT CORE, LIST 6L22.A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I1000SR ANALYZER GENERATED A FALSE NEGATIVE ANTI-HBC II RESULT FOR ONE PATIENT KNOWN TO BE POSITIVE BASED ON TESTING PERFORMED ON AN AXSYM ANALYZER AND SUPPORTING TEST RESULTS. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HBC II IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HEPATITIS B CORE ANTIBODIES LOM ABBOTT DIAGNOSTICS INT'L, LTD 93464HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCH I1000SR LN 1L86-01 SN (B)(4)| ARCH I1000SR LN 1L86-01 SN (B)(4)