BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE TOX SCREEN DRUG CUP

    MDR report key: 3963493 · Received May 30, 2014

    Report

    Report Number
    2027969-2014-00517
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 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

    CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION STRIPS. RETENTION STRIP WERE TESTED 29 DRUG-FREE DONOR URINE; ALL MET/THC/OPI/PPX/BAR/COC/OXY/BZO/MDMA RESULTS WERE NEGATIVE. NO FALSE RESULTS WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THIS ISSUE WILL BE SUBJECT TO TRACKING AND TRENDING. AS THERE WAS NO INDICATION OF A PRODUCT DEFICIENCY, CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGING A FALSE POSITIVE FOR ALL DRUGS INCLUDING COCAINE (COC). CALLER STATED A TEST WOULD BE RUN ON ONE CUP AND GET ONE RESULT; THEN THE SPECIMEN IN A DIFFERENT CUP WOULD GET A DIFFERENT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319787 ALERE TOX SCREEN DRUG CUP DRUGS OF ABUSE DKZ ALERE SAN DIEGO, INC. 4027750131 DOA3090335

    Patients

    Seq Age Sex Outcome Treatment
    1