BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN PANEL

    MDR report key: 6437326 · Received March 27, 2017

    Report

    Report Number
    2027969-2017-00053
    Event Type
    Malfunction
    Date Received
    March 27, 2017
    Date of Event
    February 28, 2017
    Report Date
    March 1, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DIO
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF A FALSE POSITIVE COCAINE WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAINS OF LOT W62368. MANUFACTURING BATCH RECORDS FOR LOT W62368 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE POSITIVE COCAINE RESULTS ON A (B)(6) INFANT. THE MOTHER WAS REPORTED AS TAKING SUBUTEX WHICH CONTAINS BUPRENORPHINE. NO CONFIRMATORY TESTING WAS CONDUCTED. THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO K060791.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218446 TRIAGE TOX DRUG SCREEN PANEL ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES DIO ALERE SAN DIEGO, INC. 94400EU W62368RB

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA