BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI DRUG ONE STEP SCREEN TEST PANEL (URINE)

    MDR report key: 4066610 · Received August 13, 2014

    Report

    Report Number
    2027969-2014-00752
    Event Type
    Malfunction
    Date Received
    August 13, 2014
    Date of Event
    July 18, 2014
    Report Date
    July 18, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DKZ
    PMA / PMN Number
    K061718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE COCAINE RESULTS WITH THE MULTI DRUG ONE STEP SCREEN TEST PANEL (URINE) TEST. WHEN THE SAMPLE WAS TESTED AT THE LAB, THE RESULT WAS POSITIVE. A COMPANY HAD EMPLOYEES IN FOR SITE ACCESS TESTING AND THE COMPANY WANTED THE 7 PANEL POINT OF CARE TEST (MULTI DRUG ONE STEP SCREEN TEST PANEL - URINE) USED AS WELL AS HAVING SAMPLES SENT TO THE LAB. WHILE DOING THE TESTING, ALL THE SPECIFIC GRAVITY AND PH READINGS WERE WITHIN THE NORMAL RANGE AND THEY WERE NEGATIVE FOR OXIDANTS. EACH TEST HAD ALL OF THE LINES SHOW UP INDICATING NEGATIVE RESULTS. SAMPLES WERE SENT TO THE LAB AND A SAMPLE FROM ONE OF THE EMPLOYEES CAME BACK AS POSITIVE FOR COCAINE. NO SAMPLES ARE AVAILABLE. LABORATORY REPORT REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482972 MULTI DRUG ONE STEP SCREEN TEST PANEL (URINE) DRUG OF ABUSE TEST DKZ ALERE SAN DIEGO, INC. DOA 174 - 691 DOA2100409

    Patients

    Seq Age Sex Outcome Treatment
    1