BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URISYS 1800

    MDR report key: 1052453 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04263
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JIL
    PMA / PMN Number
    K012397
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH FALSE NEGATIVE LEUKOCYTE RESULT THAT CONFIRMED 20-30 WBC/HPF. INITIAL RESULT NOT REPORTED, PT NOT ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 URISYS 1800 AUTOMATED URINE ANALYZER JIL ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK