BEUDAMED
    FDA Adverse Event Death Summary report: N

    CHEMSTRIP 10 UA

    MDR report key: 392686 · Received May 6, 2002

    Report

    Report Number
    1823260-2002-00133
    Event Type
    Death
    Date Received
    May 6, 2002
    Date of Event
    April 24, 2002
    Report Date
    April 24, 2002
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JRE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT BROUGHT TO ER. URINE SAMPLE RAN ON SUSPECT DEVICE. RESULT OF NEGATIVE LEUKOCYTES. RAN VISUALLY AND NEGATIVE LEUKOCYTES. PERFORMED MICROSCOPIC EXAMINATION AND 40-50 GRANULOCYTES. PT EXPIRED. TOXIC LEVELS OF ACETAMINOPHEN FOUND IN BLOOD. PT ALSO TESTED POSITIVE FOR OPIATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEMSTRIP 10 UA URINALYSIS TEST STRIP JRE ROCHE DIAGNOSTICS NA 28830241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death