BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN W/MTD

    MDR report key: 3921946 · Received May 28, 2014

    Report

    Report Number
    2027969-2014-00505
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE POSITIVE APAP RESULTS WHEN TESTING ONE PT URINE SAMPLE WITH THEIR NEW LOT OF PRODUCT AGAINST A PREVIOUS LOT. THE CURRENT LOT GAVE CONSISTENT POSITIVE APAP RESULTS AND THE PREVIOUS LOT GAVE CONSISTENT NEGATIVE APAP RESULTS ON TOW CONSECUTIVE RUNS SIDE BY SIDE. PREVIOUSLY THIS SAMPLE WAS LABELED AS +OPI, +THC WHICH WAS REPRODUCED ON ALL OF THE TESTS ON BOTH LOTS. DIAGNOSTICS AND MEDICATION FOR THIS PT ARE NOT AVAILABLE AT THIS TIME. THE EXTERNAL CONTROLS RAN NORMAL RESULTS WITH BOTH NEGATIVE AND POSITIVE. TECHNICAL SERVICE REP FOLLOW UP WITH THE CUSTOMER WHO INDICATED THE SAMPLE WAS USED AS A 'STANDARD' TO TEST FOR LOT TO LOT VARIABILITY. NO PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314798 TRIAGE TOX DRUG SCREEN W/MTD DRUG OF ABUSE TEST DJR ALERE SAN DIEGO INC 94400 W56669B

    Patients

    Seq Age Sex Outcome Treatment
    1 PREVIOUS LOT OF PRODUCT:W56647B