BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 2872908 · Received December 13, 2012

    Report

    Report Number
    3008344661-2012-00072
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C36, THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE U.S., LIST NUMBERS 1L80 AND 4P53. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATION HAS CONCLUDED THAT ARCHITECT HBSAG REAGENT 6C36-27 LOT 17473LF00 IS PERFORMING ACCEPTABLY. A REVIEW OF THE CUSTOMER COMPLAINT DATABASE SHOWS NO ADVERSE TREND FOR ARCHITECT HBSAG LIST 6C36 AND NO ATYPICAL COMPLAINT ACTIVITY FOR LOT 17473LF00; THIS IS THE ONLY FALSE NEGATIVE COMPLAINT REGISTERED FOR THIS LOT. REVIEW OF MANUFACTURING AND QUALITY TESTING RECORDS SHOWED NO ISSUES AND CLINICAL SENSITIVITY TESTING OF THE LOT ON AN I1000SR ANALYZER SHOWED ACCEPTABLE PERFORMANCE. NO PRODUCT DEFICIENCY WAS IDENTIFIED AND NO ADDITIONAL ISSUES WERE IDENTIFIED DURING THE INVESTIGATION OF THIS COMPLAINT. THERE IS NOT ENOUGH INFORMATION TO REASONABLY SUGGEST A MALFUNCTION AT THIS TIME AS THE FALSE NEGATIVE RESULT WAS GENERATED FOR A DISCRETE SAMPLE AND RETEST OF THE SAMPLE GAVE THE EXPECTED RESULT. A REVIEW OF COMPLAINT TRENDING AND SEROCONVERSION PANEL TESTING SHOWS THAT THE PRODUCT IS PERFORMING ACCEPTABLY. THIS INDICATES A SAMPLE SPECIFIC ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A (B)(6) RESULT WAS GENERATED ON THE ARCHITECT HBSAG ASSAY. A PATIENT PREVIOUSLY TESTED (B)(6) IN 2005 USING THE LUMIPULSE METHOD. THE PATIENT WAS TESTED IN (B)(6) 2012 AND GENERATED A (B)(6) RESULT ON ARCHITECT HBSAG. THE SAMPLE WAS SENT TO A REFERENCE LAB AND CONFIRMED (B)(6) (METHOD NOT STATED). THE CUSTOMER RETESTED THE SAMPLE ON ARCHITECT HBSAG QT AND YIELDED A RESULT OF (B)(6). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HBSAG KSJ ABBOTT IRELAND 17473LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR ANALYZER LIST # 1L86-01| ARCHITECT I1000SR ANALYZER LIST # 1L86-01| SERIAL # (B)(4)| SERIAL # (B)(4)