BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUICKVUE+ RAPID STREP A TEST

    MDR report key: 502032 · Received December 10, 2003

    Report

    Report Number
    MW1030489
    Event Type
    Malfunction
    Date Received
    December 10, 2003
    Report Date
    October 1, 2003
    Manufacturer
    QUIDEL CORP
    Product Code
    GTY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISCREPANCY BETWEEN KIT INSTRUCTIONS AND ACTUAL TEST. THE KIT INSTRUCTS TECHNOLOGIST TO INCUBATE TEST CASSETTE (AFTER REAGENTS ARE ADDED) FOR 5 MINUTES. THE TEST IS ONLY VALID AFTER TEST COMPLETE WINDOW IS BLUE WHICH TAKES 8-10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUICKVUE+ RAPID STREP A TEST * GTY QUIDEL CORP * ALL LOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 *