BEUDAMED
    FDA Adverse Event Other Summary report: N

    UF-1000I WITH URINALYSIS

    MDR report key: 2974169 · Received February 6, 2013

    Report

    Report Number
    1217157-2013-00017
    Event Type
    Other
    Date Received
    February 6, 2013
    Date of Event
    August 2, 2012
    Report Date
    August 2, 2012
    Manufacturer
    SYSMEX
    Product Code
    KQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT BACTERIA RESULT IS UNKNOWN.

    Description of Event or Problem · 1

    NEGATIVE BACTERIA RESULT REPORTED TO THE PHYSICIAN. CULTURE REVEALED >1000000 COLONY FORMING UNITS. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51799 UF-1000I WITH URINALYSIS UR-1000I KQO SYSMEX UF-100I

    Patients

    Seq Age Sex Outcome Treatment
    1