BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT ANTI-HCV

    MDR report key: 1840483 · Received September 21, 2010

    Report

    Report Number
    2623532-2010-00071
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 6, 2010
    Report Date
    September 17, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS INT'L, LTD
    Product Code
    MZO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6C37 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 1L79.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE YEAR AGO A MALE PATIENT, DIAGNOSED WITH MACROGLOBULINEMIA, WAS GIVEN A TRANSFUSION. THE PRE-TRANSFUSION BLOOD WORK GENERATED A (B)(6) RESULT FOR HCV AG (NON-ABBOTT) AND A (B)(6) ARCHITECT ANTI-HCV RESULT. A CURRENT SAMPLE TAKEN FROM THIS PATIENT ALSO GENERATED A POSITIVE HCV AG RESULT. THE CURRENT SAMPLE WAS ALSO TESTED WITH THE ARCHITECT ANTI-HCV ASSAY AND GENERATED A (B)(6) RESULT. THE CUSTOMER IS CONCERNED THAT AFTER ONE YEAR, THE ANTI-HCV RESULT WOULD BE (B)(6). THE PATIENT CURRENTLY HAS AN (B)(6). THE CTA RECOMMENDED (B)(6) TESTING. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ANTI-HCV FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO HEPATITIS C VIRUS MZO ABBOTT DIAGNOSTICS INT'L, LTD 87750HN00

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR ARCH I2000 ANALYZER LN: 8C89-01 SN: (B)(4)| ARCH I2000 ANALYZER LN: 8C89-01 SN: (B)(4)