BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFIA RSV FIA

    MDR report key: 7513709 · Received May 15, 2018

    Report

    Report Number
    7513709
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    March 29, 2018
    Report Date
    May 10, 2018
    Manufacturer
    QUIDEL CORP.
    Product Code
    GQG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOTED INCREASED POSITIVITY FOR RESPIRATORY SYNCYTIAL VIRUS (RSV) USING SOFIA ANALYZER. WHEN RETESTED WITH THE BIOFIRE POLYMERASE CHAIN REACTION (PCR), THE RSV WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357304 SOFIA RSV FIA ANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS GQG QUIDEL CORP. 127533

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR NO