BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM CORE REAGENT

    MDR report key: 1294703 · Received January 27, 2009

    Report

    Report Number
    1415939-2009-00013
    Event Type
    Malfunction
    Date Received
    January 27, 2009
    Report Date
    January 14, 2009
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION BEGAN WITH A REVIEW OF THE DATA THE CUSTOMER OBTAINED FOR TWO PATIENT SAMPLES THAT SHOWED A POTENTIAL (B)(6) RESULT WITH THE AXSYM CORE ASSAY. SAMPLE ID (B)(6) SHOWED (B)(6) RESULTS WITH AXSYM CORE REAGENT, LIST NUMBER 7A41-22, LOT NUMBER 67345LF00; HOWEVER, BOTH SAMPLES WERE (B)(6) WHEN TESTED WITH ARCHITECT (B)(4), LIST NUMBER 8L44-25, AND (B)(4), LIST NUMBER 1A77. DUE TO AN INSUFFICIENT SAMPLE VOLUME OF SAMPLE ID (B)(6) ONLY SAMPLE ID (B)(6) HAS BEEN FURTHER TESTED WITH ARCHITECT (B)(6), LIST NUMBER 6C34-25, LOT NUMBER 70666HN00, AND SHOWED A NON-REACTIVE RESULT. SAMPLE ID (B)(6) FURTHERMORE SHOWED A REACTIVE RESULT WHEN TESTED WITH ARCHITECT (B)(4), LIST NUMBER 6C33-25, LOT NUMBER 67753HN00. ON THE BASIS OF THE CUSTOMER'S TEST RESULTS AND THE RESULTS OBTAINED DURING THIS INVESTIGATION, SAMPLE ID (B)(6) IS CATEGORIZED AS (B)(6) AND SAMPLE ID (B)(6) IS UNABLE TO CATEGORIZE FOR THE AXSYM CORE ASSAY. TESTING OF RETAINED SAMPLES (REAGENT KIT STORED AT ABBOTT LABORATORIES) OF AXSYM CORE REAGENT, LIST NUMBER 7A41-20, LOT NUMBER 67345LF00 MET PACKAGE INSERT CLAIMS; INDEX CALIBRATOR, CONTROLS AND SENSITIVITY, DETERMINED BY TESTING THREE SENSITIVITY PANELS, SHOWED VALUES WITHIN TYPICAL RANGE. A REVIEW OF THE FINAL LOT APPROVAL AND RETAINED SAMPLE DATA SHOWED THAT THE VALUES FOR NEGATIVE CONTROL, POSITIVE CONTROL AND SENSITIVITY ARE WELL COMPARABLE. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE AXSYM CORE REAGENT (LN 7A41-20) PACKAGE INSERT (B)(4) UNDER THE LIMITATIONS OF THE PROCEDURES SECTION AND THE SPECIFIC PERFORMANCE CHARACTERISTICS SECTION. A REVIEW WAS CONDUCTED OF THE MANUFACTURING RECORDS FOR AXSYM CORE REAGENT, LIST NUMBER 7A41-20, LOT NUMBER(S) 67345LF00 (AND ANY ASSOCIATED SUB LOTS). THIS REVIEW DID NOT IDENTIFY ANY PROBLEMS RELATING TO THE CUSTOMER'S OBSERVATION. BASED ON OUR INVESTIGATION, WE HAVE DETERMINED THAT AXSYM CORE REAGENT, LIST NUMBER 7A41-20, LOT NUMBER(S) 67345LF00, IS PERFORMING ACCEPTABLY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    DURING AN IN-HOUSE INVESTIGATION, ONE PATIENT SAMPLE GENERATED A NON-REACTIVE RESULT FOR THE AXSYM CORE ASSAY. THE SAME SAMPLE TESTED REACTIVE WITH THE ARCHITECT ANTI-HBC II ASSAY AND THE PRISM HBCORE ASSAY. THERE IS NO IMPACT TO ANY PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM CORE REAGENT IN VITRO DIAGNOSTIC TEST FOR THE DETECTION OF HEPATITIS B CORE ANTIBODIES LOM ABBOTT LABORATORIES 67345LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER LN:7A83-01 SN: (B)(4)| AXSYM ANALYZER LN:7A83-01 SN: (B)(4)