BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HBS

    MDR report key: 3170995 · Received June 14, 2013

    Report

    Report Number
    3008344661-2013-00027
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Report Date
    May 29, 2013
    Manufacturer
    ABBOTT IRELAND
    Product Code
    LOM
    PMA / PMN Number
    P050051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 7C18, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 1L82.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. THE TICKET SEARCHES DETERMINED THAT THERE IS NO ATYPICAL ACTIVITY FOR THE LIKELY CAUSE LOT 23479LF00; THIS IS CURRENTLY THE ONLY COMPLAINT FOR THE LOT. THE COMPLAINT TRENDING REPORT REVIEW DETERMINED NO ATYPICAL ACTIVITY FOR THIS ISSUE. REVIEW OF THE MANUFACTURING AND QUALITY RELEASE RECORDS FOR THE LOT SHOWED NO ISSUES. CLINICAL SPECIFICITY TESTING OF THE LIKELY CAUSE REAGENT LOT MET ALL ACCEPTANCE CRITERIA, CONFIRMING THAT THIS LOT IS PERFORMING ACCEPTABLY. THE ARCHITECT (B)(6) PACKAGE INSERT DOES NOT CONTAIN ANY CORRELATION INFORMATION THAT WOULD ALLOW FOR ASSESSMENT OF THE DISCREPANT RESULTS ACROSS THE ARCHITECT AND LUMIPULSE OR QUICK CHASER METHODS. FURTHERMORE, THE ASSAY DOES NOT HAVE A (B)(6) SPECIFICITY CLAIM. THE PATIENT HISTORY IS NOT KNOWN, HOWEVER HE IS (B)(6) INDICATING AN (B)(6) AT ONE STAGE AND THE SAMPLE REMAINED HIGH (B)(6) DURING THE DILUTION LINEARITY TESTING. IN THE ABSENCE OF RETURN SAMPLE, THE SUPPLEMENTAL TESTING IN THE PACKAGE INSERT SPECIFICITY SECTION ON POTENTIALLY INTERFERING SUBSTANCES CATEGORY CANNOT BE PERFORMED. THE LUMIPULSE METHOD IS IN QUALITATIVE AGREEMENT WITH THE ARCHITECT RESULT INDICATING THAT THE ARCHITECT RESULT INTERPRETATION IS MOST LIKELY CORRECT. WHILE THE (B)(6) QUICK CHASER RESULT CONTRADICTS THE ARCHITECT RESULT, THE ASSAY PACKAGE INSERT RECOMMENDED THAT IF THE (B)(6) RESULT IS CONFIRMED TO BE REPEATEDLY (B)(6) THEN THE ARCHITECT (B)(6) RESULT IS NOT A (B)(6). BASED ON THE EVALUATION RESULTS, NO MALFUNCTION OR PRODUCT DEFICIENCY WERE IDENTIFIED AND THE PRODUCT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER QUESTIONED A (B)(6) ARCHITECT AUSAB RESULT GENERATED FROM ONE PATIENT SAMPLE. THE SAME PATIENT SAMPLE GENERATED A (B)(6) RESULT WITH ANOTHER METHOD (LUMIPULSE) AND A (B)(6) RESULT WITH THE QUICK CHASER METHOD. THE RESULT WAS REPORTED OUT AS (B)(6) FOR THE (B)(6) WITH NO IMPACT TO PATIENT MANAGEMENT. THIS ISSUE IS DEEMED REPORTABLE PER DFP01.014, EDITION 009 FOR (B)(6) RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271495 ARCHITECT ANTI-HBS LOM ABBOTT IRELAND 23479LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR ARCHITECT ANALYZER 08C89-01 SN (B)(4)| ARCHITECT ANALYZER 08C89-01 SN (B)(4)