BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN WITH MTD

    MDR report key: 1713463 · Received June 1, 2010

    Report

    Report Number
    2027969-2010-00687
    Event Type
    Malfunction
    Date Received
    June 1, 2010
    Date of Event
    May 10, 2010
    Report Date
    June 1, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED DISCREPANT RESULTS FOR COC AND APAP ON TRIAGE TOX DRUG SCREEN WITH MTD. CUSTOMER WAS NOTIFIED BY TECHNICIANS THAT THEY HAVE SEEN DISCREPANT RESULTS ON COC AND APAP FOR TOX DRUG SCREEN IN THE EMERGENCY ROOM WHEN THE SAMPLE IS REPEATED ON A NEW DEVICE. ONE SAMPLE WENT FROM POSITIVE TO NEGATIVE COC. ONE SAMPLE WENT FROM NEGATIVE TO POSITIVE COC. ONE SAMPLE HAD DISCREPANT RESULTS FOR APAP, BUT THE CALLER IS NOT SURE IF IT WENT FROM POSITIVE TO NEGATIVE OR VICE VERSA. CUSTOMER HAS NO INFO ON PT'S (MEDICAL HISTORY, MEDICATION, ETC.).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE TOX DRUG SCREEN WITH MTD TOX DRUG SCREEN DJR BIOSITE INCORPORATED 94400 W47245

    Patients

    Seq Age Sex Outcome Treatment
    1