BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT TESTPACK RSV

    MDR report key: 254345 · Received December 11, 1999

    Report

    Report Number
    1451914-1999-00022
    Event Type
    Other
    Date Received
    December 11, 1999
    Date of Event
    November 10, 1999
    Report Date
    December 8, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    GQG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON OR AROUND 11/10/99, THE ACCOUNT REPORTED A POSITIVE TESTPACK RESPIRATORY SYNCYTIAL VIRUS RESULT FOR NASOPHARYNGEAL WASH SAMPLE. THE DIRECT FLUORESCENT ANTIBODY AND CULTURE WERE NEGATIVE. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT TESTPACK RSV EIA FOR THE RAPID DETECTION OF RSV GQG ABBOTT LABORATORIES NA 58788M100

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO