BEUDAMED
    FDA Adverse Event Death Summary report: N

    BINAXNOW INFLUENZA A & B

    MDR report key: 793684 · Received December 12, 2006

    Report

    Report Number
    1221359-2006-00001
    Event Type
    Death
    Date Received
    December 12, 2006
    Date of Event
    October 16, 2006
    Manufacturer
    BINAX, INC (D.B.A. INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS)
    Product Code
    GNX
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER "SPECIMEN COLLECTION AND HANDLING" SECTION OF THE PRODUCT INSERT, THE MANUFACTURER RECOMMENDS USE OF "FRESH NASOPHARYNGEAL AND NASAL WASH/ASPIRATES" FOR BEST TEST PERFORMANCE AND UNDER THE "LIMITATIONS" SECTIONS STATES THAT "USE OF VISIBLY BLOODY SAMPLES IS NOT RECOMMENDED". THIS PATIENT'S SAMPLE (BLOODY AND POTENTIALLY A TRACHEAL ASPIRATE) REPRESENT AN OFF-LABEL USE. EVEN THOUGH THE PATIENT DIED, THIS ADVERSE EVENT WAS NOT CONSIDERED TO BE ASSOCIATED WITH THE USE OF THE BINAXNOW FLU A&B KIT SINCE THE HOSPITAL REPORTED THIS EVENT TO THE MANUFACTURER APPROXIMATELY 30 DAYS AFTER THE EVENT OCCURRED. NEITHER THE PATIENT SPECIMENS NOR THE KIT USED WERE AVAILABLE TO CONDUCT ANY FURTHER TESTING OF THESE MATERIALS AT BINAX INC, D/B/A IMPD. A COMPLETE REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT 024252 WAS CONDUCTED. THERE WERE NO ANOMALIES/DISCREPANCIES TO THE QUALITY SYSTEM. TESTING WAS PERFORMED USING THE RETAIN SAMPLES BINAXNOW INFLUENZA A&B KIT LOT 024252. ALL TEST RESULTS MET RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    BINAX, INC. D/B/A INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS (IMPD), SCARBOROUGH - TECHNICAL SERVICES RECEIVED A PHONE CALL FROM THE HOSPITAL, IN 2006 WHO REPORTED 10 FALSE POSITIVE FLU A RESULTS USING THE NOWBINAX INFLUENZA A&B KIT SINCE THE BEGINNING OF OCTOBER 2006. RESULTS WERE NEGATIVE BY DFA. THE CUSTOMER MENTIONED THAT A YOUNG CHILD THAT ALSO HAD A POSITIVE RESULT AND NEGATIVE PCR HAD DIED. UPON FURTHER INQUIRY, THE HOSPITAL PERSONNEL INDICATED THAT THE YOUNG CHILD WAS A GIRL ADMITTED IN 2006 AND DIED THE NEXT DAY. TEST RESULTS FOR THIS PATIENT WERE REPORTED TO BINAX. INC D/B/A/IMPD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BINAXNOW INFLUENZA A & B FLU A/B GNX BINAX, INC (D.B.A. INVERNESS MEDICAL PROFESSIONAL DIAGNOSTICS) NA 024252

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR