BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LATERAL FLOW DRUG SCREEN

    MDR report key: 3928494 · Received June 6, 2014

    Report

    Report Number
    2027969-2014-00551
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 13, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DKZ
    PMA / PMN Number
    K061718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGING RECEIVING DISCREPANT CORRELATION ISSUE. POSITIVE COC ON SINGLE DRUG TEST VS NEGATIVE COC ON ICUP (I-DUA-157-013). SINGLE PANEL ISCREEN COC SHOWED POSITIVE. ICUP MULTIDRUG TEST SHOWED NEGATIVE FOR COC. URINE IS FRESH, 90-100 DEGREES. NO CONFIRMATORY LAB RESULTS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331723 LATERAL FLOW DRUG SCREEN DRUGS OF ABUSE DKZ ALERE SAN DIEGO, INC. 1-DUA-157-013 DOA-3110513

    Patients

    Seq Age Sex Outcome Treatment
    1 ONE STEP COCAINE TEST STRIP