BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3047048 · Received April 10, 2013

    Report

    Report Number
    1061932-2013-00599
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 22, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE CAUSE OF THE INCIDENT IS UNKNOWN. THIS MEDWATCH REPORT IS RELATED TO MDR 1061932-2013-00598.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE INSTRUMENT DID NOT GENERATE BLAST CELL SUSPECT FLAG FOR ONE PATIENT, ON TWO SEPARATE DAYS, INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER STATED BLAST CELLS WERE IDENTIFIED THROUGH THE MANUAL SLIDES. THE ERRONEOUS RESULTS WERE IDENTIFIED DURING THE PATIENT'S OFFICE REVISIT WHERE VARIANT LYMPH FLAG WAS OBTAINED ON THE UNICEL DXH 800 SYSTEM. UPON MANUAL REVIEW, OVER 50% BLAST CELLS WERE IDENTIFIED. THE ERRONEOUS RESULTS WERE RELEASED OUT OF THE LABORATORY, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL BASED ON THE RESULTS. THE CUSTOMER INDICATED PATIENT TREATMENT WAS AFFECTED SINCE THE PATIENT WAS NOT ADMITTED TO THE HOSPITAL SOONER. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME TO DATE. THIS IS REPORT TWO OF TWO FOR THE EVENT DATE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150973 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization