BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN WITH MTD

    MDR report key: 2321756 · Received October 6, 2011

    Report

    Report Number
    2027969-2011-02084
    Event Type
    Malfunction
    Date Received
    October 6, 2011
    Date of Event
    September 14, 2011
    Report Date
    October 6, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CALLER REPORTED A POTENTIAL (B)(4) RESULT ON ONE PATIENT. PHYSICIAN'S OFFICE CALLED TO REPORT A PATIENT THAT TESTED (B)(4) FOR OPIATE AND TCA. THEY WANTED TO KNOW WHY THE TOX SCREEN WAS NOT (B)(4) FOR ACETAMINOPHEN WHEN SHE WAS TAKING TYLENOL 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE TOX DRUG SCREEN WITH MTD URINE DRUG SCREEN TEST DJR ALERE SAN DIEGO, INC. 94400 W49317B

    Patients

    Seq Age Sex Outcome Treatment
    1