BEUDAMED
    FDA Adverse Event Other Summary report: N

    UF-1000I WITH URINALYSIS WAM

    MDR report key: 3071034 · Received April 11, 2013

    Report

    Report Number
    1217157-2013-00056
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    SYSMEX
    Product Code
    LKM
    PMA / PMN Number
    K070910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT BACTERIA RESULTS WAS DUE TO A MISS-CONFIGURED RULE. THIS HAS BEEN CORRECTED AND THE SYSTEM IS OPERATING AS INTENDED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A BACTERIA RESULT OF 1+ WAS REPORTED AS NS (NOT SEEN). CUSTOMER REPORTED THAT THEY CONFIRMED ALL RESULTS BY MICROSCOPY. THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155307 UF-1000I WITH URINALYSIS WAM UF-1000I LKM SYSMEX

    Patients

    Seq Age Sex Outcome Treatment
    1