BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG QUALITATIVE

    MDR report key: 2488258 · Received March 12, 2012

    Report

    Report Number
    3008344661-2012-00012
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 27, 2012
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 1P97, ARCHITECT HBSAG QUALITATIVE , 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.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER, 08321LF00, WAS INCORRECTLY ENTERED IN TO THE SERIAL # FIELD IN THE INITIAL SUBMISSION. THIS FOLLOW-UP REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 1P97, ARCHITECT HBSAG QUALITATIVE , THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE U.S., LIST NUMBER 1L80, ARCHITECT HBSAG. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, IN-HOUSE TESTING, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. A SENSITIVITY TESTING PROTOCOL WAS EXECUTED AND MET ACCEPTANCE CRITERIA WHICH INDICATED THAT THE LOT IS PERFORMING AS EXPECTED. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO MALFUNCTION AND NO DEFICIENCY OF THE ARCHITECT HBSAG QUALITATIVE REAGENT 1P97-35 REAGENT LOT 08321LF00, WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED (B)(6) HBSAG RESULTS FOR ONE PATIENT WHILE USING THE ARCHITECT HBSAG QUALITATIVE ASSAY. THE CUSTOMER PROVIDED THE FOLLOWING RESULTS: (B)(6) 2012: INITIAL ((B)(6)) ARCHITECT HBSAG QUALITATIVE, WHEN RETESTED USING THE ARCHITECT ANTI-HBS AND ANTI-HBCII ASSAYS - BOTH WERE (B)(6); (B)(6) 2012: (B)(6) BY ROCHE METHOD; (B)(6) 2012: (B)(6) BY CARGA METHOD; (B)(6) 2012: (B)(6) - ARCH HBSAG QUALITATIVE ((B)(6)), RETESTED ON (B)(6) 2012 BY THE MONOLISA METHOD ((B)(6)). NO PATIENT INFORMATION WAS PROVIDED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT HBSAG QUALITATIVE KSJ ABBOTT IRELAND 08321LF00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT I2000 LN08C89-01, SN (B)(4)| ARCHITECT I2000 LN08C89-01, SN (B)(4)