BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 2496860 · Received March 20, 2012

    Report

    Report Number
    3008344661-2012-00014
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 16, 2012
    Report Date
    February 21, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION COULD NOT BE OBTAINED REGARDING THE OTHER FACILITY THAT TESTED THE PATIENT SAMPLE IN QUESTION. FACILITY NAME, INSTRUMENT SERIAL # OR ARCHITECT HBSAG QUALITATIVE II REAGENT LOT NUMBER IS NOT KNOWN. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 2G22, ARCHITECT HBSAG QUALITATIVE II, THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L80, ARCHITECT HBSAG. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. AN EVALUATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    PATIENT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. THE ARCHITECT HBSAG QUALITATIVE II REAGENT LOT NUMBER USED AT THE EXTERNAL LABORATORY WAS UNKNOWN, THEREFORE TESTING COULD NOT BE PERFORMED. A REVIEW OF COMPLAINT TRENDING RECORDS SHOWED NO ADVERSE TREND FOR THE ISSUE OBSERVED. THE CUSTOMER WAS ADVISED, PER PACKAGE INSERT INSTRUCTIONS, TO USE ADDITIONAL HBSAG MARKER DATA TO AID IN THE DIAGNOSIS OF THIS PATIENT. OCCULT INFECTION DOES OCCUR WHEREBY A (B)(4) TEST IS (B)(6) BUT (B)(6) SURFACE ANTIGEN (B)(6) IS UNDETECTABLE. OCCULT INFECTION MAY REPRESENT THE (B)(6) INFECTION. THE PATIENT WAS PREVIOUSLY DETERMINED TO BE A (B)(6). BASED ON THIS INVESTIGATION, NO DEFICIENCY WITH THE PRODUCT WAS DETERMINED AND NO ADDITIONAL ISSUES WERE IDENTIFIED DURING THE INVESTIGATION OF THIS COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A PATIENT KNOWN TO BE A (B)(6) CARRIER, GENERATED A FALSE NEGATIVE RESULT ON THE ARCHITECT HBSAG QUALITATIVE II ASSAY. THE PATIENT TESTED (B)(6) ON THE ARCHITECT HBSAG QUALITATIVE II ASSAY (LIST # 2G22) AT ANOTHER LABORATORY BUT WAS (B)(6). THE PATIENT ALSO TESTED (B)(6) ON THE ARCHITECT HBSAG QUALITATIVE ASSAY (LIST # 1P97) BOTH AT THE CUSTOMER'S FACILITY AND AT ANOTHER LABORATORY. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR LIST #1L86-01| ARCHITECT I1000SR LIST # 1L86-01