BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT TESTPAK RSV

    MDR report key: 249120 · Received November 5, 1999

    Report

    Report Number
    1451914-1999-00018
    Event Type
    Other
    Date Received
    November 5, 1999
    Date of Event
    September 21, 1999
    Report Date
    November 3, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    GQG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 09/21/1999 THE ACCOUNT REPORTED POSITIVE TESTPACK RSV RESULTS AND THE PATIENT WAS TREATED WITH RIBOVIRAN AND RESPOGAM. POLYMERASE CHAIN REACTION, CULTURE, DIRECT FLUORESCENT ANTIBODY 2X (BY TWO DIFFERENT METHODS), AND DIRECTOGEN WERE ALL NEGATIVE. FURTHER INFORMATION FROM THE ACCOUNT STATED THAT A BONE MARROW TRANSPLANT WAS POSTPONED DUE TO THE FALSE POSITIVE TESTPACK RSV RESULTS. NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT TESTPAK RSV EIA FOR THE RAPID DETECTION OF RSV GQG ABBOTT LABORATORIES, INC. NA 57128M200

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR TESTPAK RSV LOT NUMBER 48445M300, EXPIRATION DATE| 08/27/1999, TESTPAK RSV LOT NO. 49025M310, EXP.| DATE 09/23/1999.