BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT HBSAG

    MDR report key: 5046522 · Received September 1, 2015

    Report

    Report Number
    3008344661-2015-00023
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    May 27, 2015
    Report Date
    October 6, 2015
    Manufacturer
    ABBOTT IRELAND
    Product Code
    KSJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 6C36 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L80 AND 4P53.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED POTENTIALLY (B)(6) FOR A PATIENT SAMPLE TESTED WITH ARCHITECT HBSAG QUANTITATIVE ASSAY LIST 6C36-41, LOT UNKNOWN. (B)(6) WERE ALSO GENERATED ON THE ARCHITECT HBSAG QUALITATIVE II ASSAY, 2G22-25 LOT 49406LF00. NO PATIENT SAMPLE WAS AVAILABLE FOR RETURN. CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE OR NON-STATISTICAL TRENDS WERE IDENTIFIED. THE ARCHITECT HBSAG QUANTITATIVE ASSAY REAGENT PACKAGE INSERT WAS REVIEWED AND WAS FOUND TO ADEQUATELY ADDRESS THE ISSUE. ADDITIONAL INFORMATION PROVIDED BY ABBOTT MEDICAL AFFAIRS: A GROUP OF PATIENTS WITH (B)(6) HAS BEEN IDENTIFIED BY SENSITIVE, MOLECULAR TESTING FOR (B)(6). MEMBERS OF THIS GROUP ARE OFTEN REFERRED TO AS HAVING (B)(6) WHICH IS DIAGNOSED WHEN AN (B)(6) IS UNDETECTABLE. (B)(6) OCCURS IN A NUMBER OF CLINICAL SETTINGS AND MAY REPRESENT ACUTE INFECTION IN THE WINDOW PERIOD, (B)(6), PERSISTENCE OF REPLICATION AT LOW LEVEL AFTER RECOVERY IN THE PRESENCE OF (B)(6), OR OCCURRENCE OF AN ESCAPE MUTANT IN VACCINATED OR UNVACCINATED INDIVIDUALS NOT DETECTED BY CURRENT (B)(6) ASSAYS H. W. REESINK ET AL. (B)(6) IN BLOOD DONORS. VOX SANGUINIS (2008) 94 , 153-166 MICHAEL TORBENSON AND DAVID L THOMAS. OCCULT HEPATITIS B. LANCET INFECT DIS 2002; 2: 479-86 THE INVESTIGATION DID NOT IDENTIFY A MALFUNCTION / DEFICIENCY.

    Description of Event or Problem · 1

    THE CUSTOMER WAS QUESTIONING POSSIBLE (B)(6) ARCHITECT (B)(6) RESULTS. THE PATIENT HAD (B)(6) 2 YEARS AGO. ARCHITECT HBSAG AND ARCHITECT HBSAG QUALITATIVE II WERE (B)(6). PCR TESTING WAS (B)(6) FOR (B)(6) (54 IU/ML). THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579405 ARCHITECT HBSAG HBSAG KSJ ABBOTT IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1