BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-DRUG SCREEN TEST PANEL

    MDR report key: 1944099 · Received December 27, 2010

    Report

    Report Number
    MW5018741
    Event Type
    Malfunction
    Date Received
    December 27, 2010
    Date of Event
    December 20, 2010
    Report Date
    December 27, 2010
    Manufacturer
    INNOVACON, INC.
    Product Code
    DKZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    I DO ON-SITE DRUG TESTING AT A MFG FACILITY IN (B)(6). I AM CURRENTLY USING "MULTI-DRUG SCREEN TEST PANEL" DISTRIBUTED BY (B)(4). LOT NUMBER DOA0030282, EXP DATE 01/2012; CATALOG NUMBER DOA-354. I HAVE HAD NUMEROUS TESTS THAT FAILED TO COMPLETELY DEVELOP. THE RESULT HAS BEEN THAT I HAVE HAD TO REPEAT THE TEST USING ANOTHER TEST CASSETTE. I CONSIDER THIS A PRODUCT FAILURE. DIAGNOSIS OR REASON FOR USE: ON SITE DRUG TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-DRUG SCREEN TEST PANEL ON SITE DRUG SCREEN, COC/AMP/THC/OPI/PCP DKZ INNOVACON, INC. DOA0030282

    Patients

    Seq Age Sex Outcome Treatment
    1 Other