BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUICK IN-LINE STREP A TEST KIT

    MDR report key: 2237927 · Received September 2, 2011

    Report

    Report Number
    2024674-2011-00001
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    April 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    QUIDEL CORPORATION
    Product Code
    GTZ
    PMA / PMN Number
    K934484
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THESE APPEAR TO BE ISOLATED EVENTS INVOLVING INDIVIDUALS WITH SEVERE ALLERGIES. THERE ARE NO KNOWN ALLERGIC ISSUES WITH THE KIT REAGENTS.

    Description of Event or Problem · 1

    TWO (B)(6) FEMALES EXPERIENCED ALLERGIC REACTIONS WHILE USING THE EXTRACTION REAGENTS IN THE QUICKVUE IN-LINE STREP A TEST KIT. THE INDIVIDUALS DEVELOPED AN ALLERGY TO THE REAGENTS BUT UNK AFTER HOW MAY USES. ALLERGIC REACTIONS OCCURRED WHEN THEY JUST STARTED USING THE KIT ABOUT FOUR MONTHS AGO. SYMPTOMS INCLUDED RED EYES, DIFFICULTY BREATHING, WHEEZING, AND PROBABLY RAPID BREATHING. REAGENTS DID NOT COME INTO DIRECT CONTACT WITH THE INDIVIDUALS. ONE FEMALE USED VENTOLIN INHALATIONS AND ARUBANT (ALSO KNOWN AS AEROVENT LONG-ACTING BRONCHODILATORS). THE SECOND FEMALE ALSO USED VENTOLIN INHALATIONS AND STAYED HOME FOR A FEW DAYS UNTIL THE ALLERGIC REACTION PASSED. BOTH INDIVIDUALS ARE REPORTED TO HAVE RECOVERED FROM THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK IN-LINE STREP A TEST KIT QUICKVUE IN-LINE STEP A TEST KIT GTZ QUIDEL CORPORATION NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| O| R