BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOFIA INFLUENZA A+B FIA

    MDR report key: 2903679 · Received December 28, 2012

    Report

    Report Number
    2024674-2012-00001
    Event Type
    Death
    Date Received
    December 28, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 17, 2012
    Manufacturer
    QUIDEL CORP.
    Product Code
    GNX
    PMA / PMN Number
    K112177
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER STATED THAT NO OTHER PATIENT HISTORY WAS AVAILABLE, AND THE PATIENT RECORDS COULD NOT BE OBTAINED FROM THE FAMILY.

    Description of Event or Problem · 1

    A (B)(6)-MALE IN POOR HEALTH WAS ADMITTED TO THE EMERGENCY ROOM AND DIED SHORTLY AFTER ARRIVAL. PATIENT NASOPHARYNGEAL WASH/ASPIRATE SAMPLE WAS TESTED WITH SOFIA INFLUENZA A+B FIA AND PRODUCED A POSITIVE INFLUENZA B RESULT. SAMPLE WAS RETESTED AND PRODUCED A NEGATIVE RESULT. SAMPLE ALSO TESTED NEGATIVE WITH A DIFFERENT RAPID TEST. PATIENT TESTED POSITIVE FOR STREP A BLOOD CULTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFIA INFLUENZA A+B FIA SOFIA INFLUENZA A+B FIA GNX QUIDEL CORP. NA 212222

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death