BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NET TEST

    MDR report key: 161055 · Received March 27, 1998

    Report

    Report Number
    161055
    Event Type
    Malfunction
    Date Received
    March 27, 1998
    Date of Event
    March 14, 1998
    Report Date
    March 26, 1998
    Manufacturer
    REMEL
    Product Code
    JSX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A GONORRHEA CULTURE RECEIVED IN THE LAB ON 3/14/98. IT WAS PLATED OUT ACCORDING TO LAB POLICY. THE NEXT DAY THE CULTURE WAS READ AS A POSITIVE NEISSERIA GONORRHEA WITH MODERATE GROWTH OR GRAM NEGATIVE DIPLOCOCCI. THE ISOLATE WAS TESTED WITH THE NET TESTING KIT. CONTROLS WERE SET UP ALONG WITH THE TEST SPECIMEN. THE TEST WAS PERFORMED ACCORDING TO TESTING PROCEDURE. THE TEST REAGENT TURNED RED WHICH IS INTERPRETED AS N. GONORRHAE. THE TEST WAS REPEATED AND THE RESULTS WERE THE SAME. THE CULTURE WAS SENT FOR CONFIRMATION, WHEN THE RESULTS WERE RECEIVED, THE NET TEST WAS REPEATED BY A SECOND TECHNOLOGIST AND THE RESULTS WERE THE SAME AS THE FIRST TESTING. WHEN THE CULTURE WAS SENT OUT FOR CONFIRMATION THE RESULTS WERE NEGATIVE FOR N. GONORRHEA. ON 3/24/98 THE SPECIMEN WAS TESTED WITH A NEW LOT OF NET AND THE SPECIMEN WAS IDENTIFIED AS NEISSERIA MENINGITIDIS. THE SPECIMEN WAS REPEATED A THIRD TIME WITH THE FIRST KIT AND ALSO WAS IDENTIFIED AS N. MENINGITIDIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NET TEST LABORATORY TESTING KIT FOR IDENTIFICATION OF N. GONORRHEA JSX REMEL * 230052

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other