BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD VERITOR PHYSICIAN KIT - FLU A AND B

    MDR report key: 4422662 · Received January 13, 2015

    Report

    Report Number
    1119779-2015-00001
    Event Type
    Death
    Date Received
    January 13, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 9, 2015
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    GNX
    PMA / PMN Number
    K132692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A AND B IS A RAPID CHROMATOGRAPHIC IMMUNOASSAY FOR THE DIRECT AND QUALITATIVE DETECTION OF INFLUENZA A AND B VIRAL NUCLEOPROTEIN ANTIGENS FROM NASAL AND NASOPHARYNGEAL SWABS OF SYMPTOMATIC PTS. THE BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A AND B (ALSO REFERRED TO AS THE BD VERITOR SYSTEM AND BD VERITOR SYSTEM FLU A AND B) IS A DIFFERENTIATED TEST, SUCH THAT INFLUENZA A VIRAL ANTIGENS CAN BE DISTINGUISHED FROM INFLUENZA B VIRAL ANTIGENS FROM A SINGLE PROCESSED SAMPLE USING A SINGLE DEVICE. THE TEST IS TO BE USED AS AN AID IN THE DIAGNOSIS OF INFLUENZA A AND B VIRAL INFECTIONS. RESULTS FROM THE BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A AND B TEST SHOULD BE CORRELATED WITH THE CLINICAL HISTORY, EPIDEMIOLOGICAL DATA AND OTHER DATA AVAILABLE TO THE CLINICIAN EVALUATING THE PT. BD HAS REQUESTED ADDITIONAL INFO FROM THE (B)(6) HOSP AND (B)(6) HOSP REGARDING THE INCIDENT. BD HAS ALSO REQUESTED THE RETURN OF THE BD VERITOR KIT AND READER FOR INVESTIGATION. BD WILL FILE A SUPPLEMENTAL REPORT WHEN ADDITIONAL INFO IS PROVIDED AND INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    (B)(6) HOSP REPORTED THAT A (B)(6) -OLD INFANT WAS BEING TREATED FOR FLU A BASED ON A POSITIVE BD VERITOR TEST RESULT PROCESSED ON (B)(6) 2015. THE INFANT WAS TRANSPORTED TO (B)(6). A NEW SAMPLE WAS COLLECTED AT (B)(6) AND TESTED FOR FLU A AND THE RESULTS WERE NEGATIVE (DATE HAS NOT BEEN CONFIRMED AT THIS TIME). THE LAB AT (B)(6) RERAN THE ORIGINAL SPECIMEN (COLLECTED ON (B)(6) 2015) ON THE BD VERITOR AND RECEIVED A NEGATIVE RESULT ON (B)(6) 2015. (B)(6) THEN SENT THE ORIGINAL SPECIMEN (COLLECTED ON (B)(6) 2015) TO (B)(4) FOR INFLUENZA A AND B PCR RNA TEST AND RECEIVED A NEGATIVE RESULT. THE INFANT WAS REMOVED FROM LIFE SUPPORT ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31339 BD VERITOR PHYSICIAN KIT - FLU A AND B GNX BD DIAGNOSTIC SYSTEMS 4259123

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA Death