BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN WITH MTD

    MDR report key: 1648917 · Received March 26, 2010

    Report

    Report Number
    2027969-2010-00365
    Event Type
    Malfunction
    Date Received
    March 26, 2010
    Date of Event
    March 3, 2010
    Report Date
    March 26, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE NEGATIVE APAP RESULT ON TRIAGE TOX DRUG SCREEN WITH MTD. CUSTOMER RAN FOUR TESTS ON ONE PT URINE SAMPLE AND OBTAINED THE FOLLOWING RESULTS: W45876B: +APAP FRESH URINE. W46864B: -APAP URINE WAS COLD AFTER REFRIGERATION. W45876B: +APAP URINE AT ROOM TEMP > 30 MIN. W46864B: +APAP URINE AT ROOM TEMP > 30 MIN. CUSTOMER USED TWO DIFFERENT STRIP LOTS AND HAD THE SAME RESULTS ON THREE DIFFERENT METERS (42699, 40679 AND 47056). QC SAMPLES TESTED ON BOTH LOTS OF STRIPS WITH CORRECT RESULTS. +APAP IS REPORTED FOR THIS PT. TECH SUPPORT CHECKED WITH THE TECH WHO RAN THE TEST AND SHE RAN THE URINE RIGHT FROM THE REFRIGERATOR (THE NEGATIVE RESULT). SHE WAITED ABOUT A HALF HOUR AND REPEATED, ALL RESULTS VERIFIED.

    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 W46864B

    Patients

    Seq Age Sex Outcome Treatment
    1