BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL STREP A TEST

    MDR report key: 2949476 · Received January 29, 2013

    Report

    Report Number
    MW5028869
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 29, 2013
    Manufacturer
    QUIDEL CORP.
    Product Code
    GTZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE QUIDEL RAPID QUICKVUE IN-LINE STREP TEST DOES NOT COMPLETE THE DRAWING OF THE LIQUID OUT OF THE WELL, OR THE LIQUID LEAKS OUT OF THE SIDES OF THE TEST CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39832 QUIDEL STREP A TEST RAPID STREP TEST GTZ QUIDEL CORP. 1094000 211749

    Patients

    Seq Age Sex Outcome Treatment
    1 EXTRACTION SOLUTION: LOT 211452, EXP: 01/10/2014| CLASSICSWABS - (B)(4)