BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE CONFIRMATORY

    MDR report key: 2506165 · Received March 27, 2012

    Report

    Report Number
    3008344661-2012-00021
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    March 5, 2012
    Report Date
    March 8, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE ARCHITECT HBSAG QUALITATIVE II REAGENT 2G23-25 LOT 09047LF00 WAS ASSESSED USING AN IN-HOUSE RETAINED SAMPLE OF THIS LOT. THE INVESTIGATION TEAM WERE ABLE TO REPRODUCE THE CUSTOMER RESULTS IN HOUSE; THE (B)(6) REACTIVITY OF THE CUSTOMER RETURNED PATIENT SAMPLE WAS NOT CONFIRMED FOLLOWING THE ASSAY CALCULATION ALGORITHM AS PER REAGENT PACKAGE INSERT. THE INVESTIGATION TEAM FURTHER COMPLETED (B)(6) DNA PCR ANALYSIS ON THE CUSTOMER RETURNED PATIENT SAMPLE WITH A HIGH SENSITIVITY RESEARCH METHOD WHICH RETURNED (B)(6) RESULTS. FURTHER SEQUENCING ANALYSIS OF THE SAMPLE INDICATED THAT THIS PARTICULAR PATIENT HAS MUTATIONS IN BOTH LOOP ONE AND LOOP 2 OF THE 'A' DETERMINANT OF THE (B)(6). IN PARTICULAR, THERE IS A MUTATION FROM CYSTEINE TO TYROSINE AT AMINO ACID 139 AS WELL AS MUTATIONS AT AMINO ACID POSITIONS 144 AND 145. G145R IS A PRIME EXAMPLE OF AN IMMUNE ESCAPE MUTATION, IN ADDITION, THE C139Y MUTANT HAS BEEN REPORTED TO BE POORLY REACTIVE WITH (B)(6)VACCINE PLASMA. IT IS WELL ESTABLISHED IN THE SCIENTIFIC LITERATURE THAT DISULFIDE BONDS INVOLVING CYSTEINES LOCATED IN THE 'A' DETERMINANT ARE OF GREAT IMPORTANCE FOR THE CONFORMATIONAL STRUCTURE AND ANTIGENIC PROPERTIES OF (B)(6) AND THIS MUTATION MIGHT AFFECT THE ABILITY OF THE NEUTRALIZATION REAGENT TO BIND. THE ARCHITECT HBSAG QUALITATIVE II ASSAY HAS BEEN DESIGNED TO HAVE THE ABILITY TO BETTER DETECT (AS (B)(6) ) THE (B)(6) MUTANT THR-123-ALA AND TO HAVE THE EQUIVALENT OR BETTER ABILITY TO DETECT (AS (B)(6) ) OTHER (B)(6) MUTANTS WHEN COMPARED TO ANOTHER COMMERCIALLY AVAILABLE ASSAY. THE 9 MEMBERS OF THE (B)(6) MUTANT PANEL USED TO ESTABLISH THIS CLAIM WERE ALSO TESTED WITH REAGENT 2G23-25 LOT 09047LF00 TO DETERMINE IF THE MUTANT DETECTION POWER OF THE LOT HAD BEEN IMPACTED. ALL 9 MUTANTS WERE CONFIRMED (B)(6) . DURING THIS INVESTIGATION THE TEAM ALSO PERFORMED AN IN-HOUSE TEST WHICH WAS USED TO EVALUATE THE PERFORMANCE OF THE PRE-TREATMENT REAGENT. DURING THIS TEST A CERTAIN (B)(6) CONCENTRATION HAD TO BE NEUTRALIZED BY THE ASSAY. TEST RESULTS OBTAINED REVEALED THAT THE ASSAY NEUTRALIZED THIS HIGH CONCENTRATION PER THE ACCEPTANCE CRITERIA, THEREBY, SHOWING ACCEPTABLE PERFORMANCE AND MEETING RELEASE SPECIFICATION. A REVIEW OF MANUFACTURING AND QUALITY TESTING RECORDS WAS PERFORMED FOR ARCHITECT HBSAG QUALITATIVE II REAGENT 2G23-25 LOT 09047LF00 AND NO ISSUES WERE IDENTIFIED RELATED TO THE COMPLAINT ISSUE. RELEASE TESTING OF THIS MATERIAL REQUIRES MEETING ACCEPTANCE CRITERIA FOR NEUTRALISATION OF (B)(6) PANELS MANUFACTURED AT A CONCENTRATION OF 1000NG/ML OF (B)(6) . THE INVESTIGATION TEAM WERE ABLE TO DEMONSTRATE THROUGH INVESTIGATION ANALYSIS THAT THIS REAGENT LOT IS STILL CAPABLE TO NEUTRALISE SUCH PANELS IN A MANNER COMPARABLE TO THAT WHEN THE REAGENT LOT WAS RELEASED WITHIN ACCEPTANCE CRITERIA AND ALSO COMPARABLE OTHER REAGENT LOTS. THE INVESTIGATION TEAM ALSO REVIEWED THE CUSTOMER COMPLAINT DATABASE AND NO ATYPICAL TREND HAS BEEN IDENTIFIED FOR 2G23-25 REAGENT LOT 09047LF00. THIS INVESTIGATION HAS CONCLUDED THAT THE 2G23 REAGENT LOT USED AT THE CUSTOMER SITE IS PERFORMING ACCEPTABLY AND WITHIN RELEASE SPECIFICATIONS AND NO PRODUCT DEFICIENCY HAS BEEN IDENTIFIED. THE ISSUE OBSERVED WITH THE CUSTOMER RETURNED PATIENT SAMPLE SEEMS TO BE DRIVEN BY THE SPECIFIC VIRAL MUTATION CARRIED BY THE PATIENT. UNFORTUNATELY THE MUTANTS PRESENT IN THIS PATIENT SAMPLE WERE NOT NEUTRALISED BY 2G23 CONFIRMATORY ASSAY. NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2G23-25, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 1L81. PATIENT CODE: NO CONSEQUENCES OR IMPACT TO PATIENT (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER GENERATED (B)(6) QUALITATIVE II CONFIRMATORY RESULTS THAT WERE NOT NEUTRALIZED IN THE CONFIRMATORY TESTING FOR A SAMPLE FROM A PATIENT WITH CHRONICAL (B)(6) WITHOUT DELTA AGENT. THE (B)(6)QUALITATIVE II NEAT RESULTS WERE ABOVE (B)(6) QUALITATIVE II CONFIRMATORY C2 = 5.2 INDEX, WHICH (B)(6). ADDITIONAL DILUTION OF THE SAMPLE AT 1: 20,000 GENERATED A (B)(6) QUALITATIVE II CONFIRMATORY (B)(6). ADDITIONALLY, THE SAMPLE WAS (B)(6) DNA POSITIVE, AND SCANTABODIES (B)(6) ANTIBODY TESTING WAS NEGATIVE. THE CUSTOMER PROVIDED THE FOLLOWING DATA AS FOLLOWS: (B)(6) QUALITATIVE II: (B)(6): (B)(6). THE (B)(6) QUALITATIVE II CONFIRMATORY RESULTS WERE NOT REPORTED OUT OF THE LAB, THEREFORE, THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HBSAG QUALITATIVE CONFIRMATORY KSJ ABBOTT IRELAND 09047LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT ANALYZER, LIST # AND SERIAL # UNKNOWN| SERIAL # UNKNOWN| ARCHITECT ANALYZER, LIST # UNKNOWN