BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEST NILE VIRUS ASSAY

    MDR report key: 813190 · Received February 6, 2007

    Report

    Report Number
    MW1041853
    Event Type
    Injury
    Date Received
    February 6, 2007
    Date of Event
    December 14, 2006
    Report Date
    January 29, 2007
    Manufacturer
    NOT IDENTIFIED
    Product Code
    NOP
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVED: 1) INCORRECT TEST RESULTS FROM USE OF FDA APPROVED OR "NEW" SCREENING TEST FOR WEST NILE VIRUS IN DONATED BLOOD. 2) EVENT OCCURRED AT BLOOD DONOR UNIT. 3) INCORRECT RESULTS CAUSED DONOR'S BLOOD TO BE REFUSED FOR TRANSFUSION AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WEST NILE VIRUS ASSAY NUCLEIC ACID TEST (NAT) NOP NOT IDENTIFIED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening