BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN WITH MTD

    MDR report key: 1678408 · Received May 5, 2010

    Report

    Report Number
    2027969-2010-00547
    Event Type
    Malfunction
    Date Received
    May 5, 2010
    Date of Event
    April 15, 2010
    Report Date
    May 5, 2010
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS. ADDITIONAL SERIAL: (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL FALSE NEGATIVE APAP RESULT WHEN TESTING FROZEN URINE SAMPLE ON DIFFERENT METERS AND DEVICE LOT NUMBERS. CUSTOMER OBTAINED POTENTIAL FALSE NEGATIVE APAP RESULT X6 FROZEN URINE SAMPLE ON DIFFERENT METERS USING DEVICE LOT NUMBER W47200. THE CUSTOMER TESTED AND OBSERVED POSITIVE APAP X4 WHEN USING DEVICE LOT NUMBER W46864. CUSTOMER CALLED BACK TO STATE THAT A (B)(6) MALE WENT INTO THE ER. ER ADMITTING DIAGNOSIS UNK; DISCHARGED; PRESCRIPTION AND OTC MEDICATIONS UNK. CONTROLS WERE RUN AND PASSED.

    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 W46864

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR