BEUDAMED
    FDA Adverse Event Other Summary report: N

    SOFIA INFLUENZA A AND B FIA KIT

    MDR report key: 2871763 · Received December 11, 2012

    Report

    Report Number
    MW5028061
    Event Type
    Other
    Date Received
    December 11, 2012
    Date of Event
    July 1, 2012
    Report Date
    December 11, 2012
    Manufacturer
    QUIDEL CORP
    Product Code
    GNX
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THREE PTS WERE TESTED FOR INFLUENZA B STARTING (B)(6) 2012 AND EACH RECEIVED FALSE POSITIVE RESULTS. CONFIRMATION OF FALSE POSITIVE RESULTS WAS PERFORMED THROUGH TWO ADDITIONAL TEST METHODS. THERE ARE NO KNOWN ADVERSE CONSEQUENCES. CALLER STATES THERE HAS BEEN A RECALL INSTITUTED (B)(4) 2012 FOR THIS DEVICE, BUT THE SPECIFIC LOT NUMBER USED FOR THIS TEST WAS NOT LISTED IN THE RECALL.

    Description of Event or Problem · 2

    THREE PTS WERE TESTED FOR INFLUENZA B STARTING (B)(6) 2012 AND EACH RECEIVED FALSE POSITIVE RESULTS. CONFIRMATION OF FALSE POSITIVE RESULTS WAS PERFORMED THROUGH TWO ADDITIONAL TEST METHODS. THERE ARE NO KNOWN ADVERSE CONSEQUENCES. CALLER STATES THERE HAS BEEN A RECALL INSTITUTED (B)(4) 2012 FOR THIS DEVICE, BUT THE SPECIFIC LOT NUMBER USED FOR THIS TEST WAS NOT LISTED IN THE RECALL.

    Description of Event or Problem · 3

    THREE PTS WERE TESTED FOR INFLUENZA B STARTING (B)(6) 2012 AND EACH RECEIVED FALSE POSITIVE RESULTS. CONFIRMATION OF FALSE POSITIVE RESULTS WAS PERFORMED THROUGH TWO ADDITIONAL TEST METHODS. THERE ARE NO KNOWN ADVERSE CONSEQUENCES. CALLER STATES THERE HAS BEEN A RECALL INSTITUTED (B)(4) 2012 FOR THIS DEVICE, BUT THE SPECIFIC LOT NUMBER USED FOR THIS TEST WAS NOT LISTED IN THE RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOFIA INFLUENZA A AND B FIA KIT TESTING KIT GNX QUIDEL CORP 214851
    2 SOFIA INFLUENZA A AND B FIA KIT CASSETTE GNX QUIDEL CORP 214755

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR
    2 6 YR
    3 59 YR