BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROFILE-V

    MDR report key: 3091408 · Received April 23, 2013

    Report

    Report Number
    3091408
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTOX DIAGNOSTICS, INC.
    Product Code
    DJG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    EMERGENCY ROOM PHYICIANS NOTED AN ABNORMAL INCREASE IN POSITIVE TOXICOLOGY SCREENS. QUESTIONING THE LAB, IT WAS FOUND THAT THERE HAD BEEN AN "URGENT MEDICAL DEVICE RECALL" ON MEDTOX DEVICES USED FOR QUALITATIVE DETECTION OF "DRUGS OF ABUSE" IN HUMAN URINE. AN ALL INCLUSIVE LIST OF PATIENTS WITH RESULTING POSITIVE URINE TOX SCREENS USING THE RECALL INVOLVED LOT NUMBERS WAS PRODUCED. FOLLOW-UP WITH PATIENTS AND FAMILY IS IN PROGRESS.MANUFACTURER PROVIDED REPLACEMENT TO ALL AFFECTED LOTS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?URINE TOX SCREENING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED: OTHER.IF YOU ANSWERED OTHER TO THE QUESTION ABOVE, PLEASE SPECIFY:PROFILE-V MEDTOX SCAN TEST DEVICES - 13 PANEL.IS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.IF YOU ANSWERED YES TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:PHYSICIANS NOTED WHAT APPEARED TO BE ABNORMALLY HIGH POSITIVE TOX SCREENSWHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:QUESTIONABLE PATIENT RESULTS.PLEASE DESCRIBE ANY FOLLOW UP ACTIONS:DISCONTINUED ALL USE OF PRODUCT.MANUFACTURER NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173983 PROFILE-V URINE ANALYZER DJG MEDTOX DIAGNOSTICS, INC. 4881 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *