BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2242168 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01390
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 11, 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
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RAW DATA ANALYSIS REVEALED THAT THE ALGORITHM ATTEMPTED TO EXCLUDE THE COUNTING OF THE MATURE RBC AS RETICULOCYTES. BASED ON THE MANUAL ABSOLUTE COUNT, THE RETIC EVENTS WERE UNDER RECOVERED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. ROOT CAUSE IS UNKNOWN, BUT THE INSTRUMENT GENERATED FLAGS TO ALERT THE OPERATOR TO FURTHER REVIEW THE SPECIMEN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS RETICULOCYTE RESULTS WITH INSTRUMENT GENERATED FLAGS FOR ONE PATIENT SAMPLE. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, AND WERE QUESTIONED BY THE PHYSICIAN. MANUAL RETIC COUNTS WERE PERFORMED AT ALTERNATE FACILITY ON A RE-DRAW SAMPLE FROM THE PATIENT ON THE NEXT DAY, AND THE RESULT WAS CONSIDERED CORRECT. THE PATIENT RESULTS ARE SHOWN. 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 23 YR