BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 1100

    MDR report key: 1006898 · Received February 26, 2008

    Report

    Report Number
    1823260-2008-01842
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIO
    PMA / PMN Number
    K033548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT URINE SAMPLE WITH DISCREPANT RESULTS FOR BLOOD, COMPARED TO REPEAT RESULTS FROM ANOTHER ANALYZER - SAME METHODOLOGY. INITIAL RESULT GAVE 50 UL; REPEAT RESULTED NEGATIVE. MICROSCOPIC EXAM OF SAME SAMPLE SHOWED NEGATIVE FOR BLOOD. NO ADVERSE EVENTS REPORTED IN ASSOCIATION WITH THE RESULTS. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URISYS 1100 AUTOMATED URINE ANALYZER JIO ROCHE DIAGNOSTICS U1100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK QUINIDINE| COLCHICINE