BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-TEST INFLUENZA A

    MDR report key: 19754 · Received February 15, 1995

    Report

    Report Number
    MW1005136
    Event Type
    Malfunction
    Date Received
    February 15, 1995
    Report Date
    February 13, 1995
    Manufacturer
    BECTON DICKINSON MICROBIOLOGY SYSTEM
    Product Code
    GNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN THE LITERATURE PROVIDED IN THE TEST THE CO EXPLAINS THAT THE "METHOD OF CHOICE" FOR COLLECTION OF SPECIMEN IS A NASAL WASHING/ASPIRATION. IT THEN ONLY PROVIDES A PHARYNGEAL SWAB FOR USE WITH THE KIT. WHEN RPTR CALLED TO ASK WHY CO HAD INCLUDED ONLY THE SWAB CO STATED THAT CONSUMER STUDIES REVEALED THAT MOST PHYSICIANS WOULD NOT PERFORM NASAL ASPIRATES AND WOULD PREFER TO COLLECT PHARYNGEAL SWABS. RPTR'S CONCERN IS THAT CO HAS CLEARLY STATED IN ITS LITERATURE THAT THE METHOD OF CHOICE FOR COLLECTION IS NASAL WASHING/ASPIRATE. IT THEN DOES NOT PROVIDE THE PRACTITIONER WITH THE TOOLS TO COLLECT THAT SPECIMEN (TOOLS THAT MANY PRACTIONERS MAY NOT HAVE READILY AVAILABLE IN THEIR OFFICE). UNWITTING PRACTITIONERS AND CO ARE LEAVING THEMSELVES OPEN FOR LEGAL ACTION IF A PT HAS A FALSE NEGATIVE TEST USING A SPECIMEN OTHER THAN THE "METHOD OF CHOICE" AND SUFFERS COMPLICATIONS FROM THEIR ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Q-TEST INFLUENZA A GNX BECTON DICKINSON MICROBIOLOGY SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 *