BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 2852897 · Received November 30, 2012

    Report

    Report Number
    3008344661-2012-00069
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 22, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INITIALLY OBSERVED A (B)(6) ARCHITECT HBSAG ASSAY (B)(6) FOR A SERUM SAMPLE. ADDITIONAL SAMPLES FROM THE SAME PATIENT WERE ALSO TESTED FROM A BLOOD BAG AND WHEN THESE SAMPLES WERE ASSESSED, (B)(6) RESULTS WERE OBTAINED (B)(6). A BLOOD BAG SAMPLE FROM THIS PATIENT WAS THEN ALSO ASSESSED USING NUCLEIC ACID TESTING (DNA ANALYSIS) AND A (B)(6) WAS RETURNED. AS NO PATIENT SAMPLE WAS AVAILABLE TO INVESTIGATE THIS ISSUE, IN-HOUSE RETAINED SAMPLES OF ARCHITECT HBSAG REAGENT LIST 06C36-22, LOT 22003LF00, WERE ASSESSED. THE PERFORMANCE OF THIS ARCHITECT HBSAG REAGENT WAS ASSESSED BY TESTING THE REAGENT KIT AGAINST TWO SEROCONVERSION PANELS (PHM909 AND PHM910). (B)(6). ALL RESULTS MET VALIDITY AND ACCEPTANCE CRITERIA, DEMONSTRATING THAT ARCHITECT HBSAG REAGENT LIST 06C36-22, LOT 22003LF00, IS PERFORMING ACCEPTABLY WITH REGARDS TO CLINICAL SENSITIVITY. A REVIEW OF THE MANUFACTURING AND CUSTOMER RELEASE TEST DATA FOR ARCHITECT HBSAG REAGENT 06C36-22, LOT 22003LF00, WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT HBSAG REAGENT PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S CURRENT ISSUE. FROM THE RESULTS OF THIS CURRENT EVALUATION, IT CAN BE CONCLUDED THAT THE ARCHITECT HBSAG REAGENT LIST NUMBER 06C36-22, LOT NUMBER 22003LF00 IS PERFORMING ACCEPTABLY. NO MALFUNCTION OF THE PRODUCT WAS DETERMINED.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 06C36-27 THAT HAS SIMILAR PRODUCTS DISTRIBUTED IN THE US, LIST NUMBERS 01L80 AND 04P53. PATIENT PROBLEM CODE: NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS A (B)(6) ARCHITECT HBSAG ASSAY RESULT FOR ONE DONOR SAMPLE. BLOOD TESTED DIRECTLY FROM THE DONOR UNIT GENERATED (B)(6) RESULTS OF 0.02 AND 0.04 IU/ML. BLOOD TESTED DIRECTLY FROM A SEPARATE COLLECTION TUBE GENERATED A (B)(6) RESULT OF 0.05 IU/ML. NUCLEIC ACID TESTING GENERATED A (B)(6) RESULT. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THERE IS NO DONOR/PATIENT ADVERSE IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HBSAG KSJ ABBOTT IRELAND 22003LF00

    Patients

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