BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2233762 · Received September 3, 2011

    Report

    Report Number
    1061932-2011-01346
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    July 29, 2011
    Report Date
    August 4, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN 5ML EDTA TUBE, STORED AT ROOM TEMPERATURE, AND PROCESSED WITHIN 4 HOURS. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT, AND WERE WITHIN QC SPECIFICATIONS. THE CUSTOMER DOES NOT REPORT THE NRBC % DIRECTLY FROM THE INSTRUMENT, BUT USES IT AS A FLAG TO SEND THEM TO THE SCOPE. SERVICE WAS NOT DISPATCHED FOR THIS ISSUE. RAW DATA WAS PROVIDED, HOWEVER, THE DATA ANALYSIS HAS NOT BEEN COMPLETED YET. THE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE RELATED EVENTS ON THE SAMPLES FROM THIS PATIENT ARE REPORTED IN MEDWATCH #1061932-2011-01340, AND -01344 TO -01348.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS DIFFERENTIAL AND NRBC RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. MANUAL SMEAR RESULTS WERE REPORTED OUT AS CORRECT RESULTS. THERE WAS NO DEATH, INJURY, OR IMPACT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1