BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN WITH MTD

    MDR report key: 2251575 · Received August 10, 2011

    Report

    Report Number
    2027969-2011-01775
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    April 4, 2011
    Report Date
    August 10, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE APAP. PT TESTED APAP NEGATIVE AND OPI POSITIVE. PT IS TAKING VICODIN 5MG (HYDROCODONE) /500MG (APAP), 1 QID. ON (B)(6) 2011, URINE WAS TESTED AT 9:20AM WITH TOX W48841B, APAP - AND OPI +. ALL CONTROLS PASSED OK. NO ABNORMALITY WAS OBSERVED ON URINE SAMPLE. NO URINE SAMPLE WAS SAVED. NO INFO ON PT'S CLINICAL CONDITION AND DIAGNOSIS WAS PROVIDED. THE LAB IS USING TOX TO MONITOR PTS TREATED WITH DIFFERENT DRUGS. DOCTORS JUST WANT TO KNOW IF PTS TAKE THE DRUG OR NOT. NO CONFIRMATORY TEST WAS DONE.

    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 W48841B

    Patients

    Seq Age Sex Outcome Treatment
    1