BEUDAMED
    FDA Adverse Event Other Summary report: N

    UF-1000I WITH URINALYSIS

    MDR report key: 2949618 · Received February 4, 2013

    Report

    Report Number
    1217157-2013-00002
    Event Type
    Other
    Date Received
    February 4, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SYSMEX
    Product Code
    CGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER IDENTIFIED TWO INCIDENTS OF DISCORDANT BACTERIA RESULTS. CUSTOMER FURTHER STATES THAT CONTROLS ARE WITHIN RANGE. REASON FOR THE DISCORDANT BACTERIA RESULTS IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TWO SAMPLE RESULTS FOR BACTERIA ON THE UF-1000I DID NOT CORRELATE WITH THE MANUAL MICROSCOPICS. THE UF-1000I IS REPORTING THE SAMPLES AS NEGATIVE FOR BACTERIA BUT THE MANUAL REVIEW BY THE HOSPITAL STAFF REPORTS THEM AS POSITIVE. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46402 UF-1000I WITH URINALYSIS UF-1000I CGX SYSMEX

    Patients

    Seq Age Sex Outcome Treatment
    1