BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UF-1000I WITH URINALYSIS WAM

    MDR report key: 2982801 · Received January 30, 2013

    Report

    Report Number
    1217157-2012-00086
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    August 9, 2012
    Report Date
    August 9, 2012
    Manufacturer
    SYSMEX
    Product Code
    LKM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED THAT WHEN RUNNING A PT SAMPLE, THE AUWI ANALYZER AUTO VERIFIED INCORRECT PT RESULTS. THE CUSTOMER CLAIMS THAT THE SAMPLE WAS NOT TESTED ON THE AUWI AND THERE ARE NO RESULTS IN EITHER THE ATLAS OR UF1000I IPU. RESULTS EXIST IN THE WAM SOFTWARE FOR THE PT WITH THE ORIGINAL ACCESSION NUMBER (B)(4) HOWEVER THE RESULTS ARE INCORRECT AND WERE REPORTED TO THE PHYSICIAN. THE CUSTOMER CREATED A NEW ACCESSION NUMBER (B)(4) FOR THE SAME SAMPLE AND TESTED IT ON THE AUWI AND OBTAINED DIFFERENT RESULTS THAT WERE REPORTED TO THE PHYSICIAN AND THE INCORRECT REPORTED RESULTS AMENDED. THE MFR OF THE SOFTWARE HAS IDENTIFIED AN ERROR IN THE SOFTWARE THAT CAUSES DATA TO BE OVERWRITTEN WITH PRIOR REPORTED RESULTS DUE TO AN INVALID YR BEING POPULATED IN THE "CENTURY BREAK" FIELD.

    Description of Event or Problem · 1

    PT DEMOGRAPHIC TRANSCRIPTION ERROR WITH URINALYSIS SYSTEM WAM SOFTWARE. THERE WAS NO REPORT OF INJURY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41601 UF-1000I WITH URINALYSIS WAM UF-1000I LKM SYSMEX

    Patients

    Seq Age Sex Outcome Treatment
    1