BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 2764926 · Received September 28, 2012

    Report

    Report Number
    3008344661-2012-00055
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 3, 2012
    Report Date
    September 5, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED ON INTERNATIONAL PRODUCT ARCHITECT HBSAG QUALITATIVE II, LIST NUMBER 2G22, THAT HAS A SIMILAR U.S. PRODUCT DISTRIBUTED IN THE U.S., ARCHITECT HBSAG LIST NUMBER 1L80 AND ARCHITECT HBSAG QUALITATIVE, LIST NUMBER 4P53. (B)(4). AN EVALUATION IS IN PROGRESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A (B)(6) ARCHITECT HBSAG QUALITATIVE II RESULT OF (B)(6) WAS GENERATED FOR A DONOR PATIENT THAT TESTED (B)(6) DNA. THE SAMPLE RETESTED (B)(6) ON THE ARCHITECT ANALYZER. TESTING USING THE ORTHO VITROS HBSAG METHOD WAS (B)(6). TESTING USING THE ROCHE HBSAG METHOD WAS (B)(6). TESTING AT ANOTHER FACILITY USING THE ARCHITECT HBSAG ASSAY (LIST 06C36) WAS REPEATEDLY (B)(6). NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HBSAG QUALITATIVE II KSG ABBOTT IRELAND 15619LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000SR, LIST 03M74-80, SERIAL (B)(4)| ARCHITECT I2000SR, LIST 03M74-80, SERIAL (B)(4)