BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN WITH MTD

    MDR report key: 2022514 · Received February 15, 2011

    Report

    Report Number
    2027969-2011-00317
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 15, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES MAY HAVE CONTAINED METABOLITE LEVELS NEAR THE CUT OFF LEVEL FOR EACH DRUG CLASS. NO SAMPLE WAS RETURNED FOR TESTING; PRODUCT SUPPORT WAS UNABLE TO VERIFY THE CUSTOMER'S RESULT. PRODUCT SUPPORT COULD NOT RULE OUT ANY SAMPLE SPECIFIC OR ENVIRONMENTAL FACTOR THAT MAY HAVE AFFECTED ANALYTE RECOVERY. THIS ISSUE WILL BE TRACKED AND TRENDED TO DETECT ANY FURTHER OCCURRENCE. AN INVESTIGATION OF EACH LOT NUMBER INVOLVED IN THIS CASE INDICATES THAT THE NUMBER OF CALLS DOES NOT EXCEED HISTORIC LEVELS OF CALL VOLUME PER LOT FOR THE PRODUCT(S) INVOLVED. ROOT CAUSE ANALYSIS WILL NOT BE REQUESTED AT THIS TIME. INFO RELATED TO THIS CALL IS CAPTURED AND IS AVAILABLE IF ROOT CAUSE ANALYSIS IS REQUIRED IN THE FUTURE. ALL COMPLAINTS ARE SUBJECT TO ROUTINE TRACKING AND TRENDING. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE NEGATIVE ACETAMINOPHEN RESULTS USING THE TRIAGE TOX DRUG SCREEN METER: RESULTS AS FOLLOWS: PT'S URINE SAMPLE WAS RUN ON THE TRIAGE METER THREE TIMES AND ALL TEST RESULTS WERE NEGATIVE FOR (B)(6). PT SAMPLE WAS THEN ANALYZED USING GC/MS AND CAME BACK POSITIVE FOR (B)(6). NO URINE ANALYSIS WAS PERFORMED. SAMPLE WAS CLEAR AND NOT CENTRIFUGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE TOX DRUG SCREEN WITH MTD DRUGS OF ABUSE TEST DJR ALERE SAN DIEGO, INC. 94400 W48469

    Patients

    Seq Age Sex Outcome Treatment
    1