BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE II

    MDR report key: 2901531 · Received January 8, 2013

    Report

    Report Number
    3008344661-2013-00003
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 16, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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 US PRODUCT DISTRIBUTED IN THE U.S., ARCHITECT HBSAG LIST NUMBER 1L80 AND ARCHITECT HBSAG QUALITATIVE, LIST NUMBER 4P53. (B)(4). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS PERFORMED IN ORDER TO INVESTIGATE THIS ISSUE. NO RETURNED MATERIALS WERE AVAILABLE FOR THE EVALUATION AND THEREFORE; A RETAINED KIT OF THE PRODUCT LOT IN QUESTION WAS EVALUATED. CLINICAL SENSITIVITY TESTING PERFORMED IN HOUSE USING A RETAINED KIT OF REAGENT LOT 17522LF00 AND TESTING SERO-CONVERSION PANELS MET ACCEPTANCE CRITERIA. A REVIEW OF QUALITY RECORDS FOR THE MANUFACTURE AND RELEASE OF THIS REAGENT LOT SHOWS NO ISSUES. THE TICKET SEARCHES DETERMINED THAT THERE IS NO UNUSUAL ACTIVITY FOR THE LOT IN QUESTION. THE (B)(6) RESULTS INDICATE THE DONOR IS IN THE RECOVERY PHASE OF (B)(6) INFECTION. PER THE ASSAY PACKAGE INSERT, RESULTS SHOULD BE USED IN CONJUNCTION WITH PATIENT HISTORY AND OTHER HEPATITIS MARKERS FOR DIAGNOSIS OF ACUTE AND CHRONIC INFECTION. BASED ON THE EVALUATION RESULTS, NO MALFUNCTION WAS IDENTIFIED AS RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE GENERATED A (B)(6) FOR THE ARCHITECT HBSAG QUALITATIVE II ASSAY. THE SAME PATIENT SAMPLE GENERATED (B)(6) RESULTS FOR THE (B)(6) AND THE (B)(6). THE SAME PATIENT SAMPLE WAS THEN TESTED (B)(6) FOR THE (B)(6) AT A REFERENCE LAB WITH A DIFFERENT METHOD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9516 ARCHITECT HBSAG QUALITATIVE II KSJ ABBOTT IRELAND 17522LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I1000SR 01L86-4 SN (B)(4)| ARCHITECT I1000SR 01L86-4 SN (B)(4)