BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URS - 1K URINALYSIS STRIPS

    MDR report key: 473766 · Received July 24, 2003

    Report

    Report Number
    MW1029068
    Event Type
    Malfunction
    Date Received
    July 24, 2003
    Date of Event
    June 27, 2003
    Report Date
    July 14, 2003
    Manufacturer
    L.W. SCIENTIFIC, INC.
    Product Code
    JJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    USED URS -1K KETONE STRIPS WHILE ILL - STRIPS GAVE A GRAY READING (NOT AN OPTIONAL COLOR TO DETECT KETONES.) PARENT GIVEN ANOTHER BLAND (BAYER) KETONE STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URS - 1K URINALYSIS STRIPS URINE REAGENT STRIPS JJL L.W. SCIENTIFIC, INC. * D1006Z

    Patients

    Seq Age Sex Outcome Treatment
    1 *