BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2210138 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01064
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    February 9, 2010
    Report Date
    February 19, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECIFICATIONS WITH RESPECT TIO CONTROLS (ACCURACY) AND REPEATABILITY (PRECISION). CONTROLS ARE RUN ONCE PER SHIFT. FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA ANALYSIS WAS CONDUCTED. FOR THIS SPECIMEN, A SECOND MATURE RED BLOOD CELL (RBC) POPULATION HEAVILY OVERLAPS THE RETICULOCYTE POPULATION IN THE RETICULOCYTES VIEW AND THE ALGORITHM CAN NOT DISCRIMINATE MATURE RBC FROM RETICULOCYTES IN RETICULOCYTES REGION. THERE ARE NO UNGHOSTED CELLS IN THE SAMPLE. THE SAMPLE WAS RUN TRICE, AND IT WAS OBSERVED THAT THE RECOVERED RETICULOCYTES WERE DIFFERENT FOR EACH. BECAUSE OF THE HEAVY OVERLAP AMONGST THE MATURE RBC POPULATIONS, THE ALGORITHM COULD NOT DETECT THE PRESENCE OF A SECOND MATURE RBC POPULATION AND GENERATE AN R (REVIEW) FLAG WITH THE RESULTS. ROOT CAUSE BASED ON A RAW DATA IS THAT THE SPECIMEN HAD TWO POPULATIONS OF RBCS THAT WERE HEAVILY OVERLAPPED AND THE ALGORITHM COULD NOT DISCRIMINATE THE RETICULOCYTE CELLS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN JAN 1, 2008 AND OCTOBER 23, 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS LOW RETICULOCYTE RESULTS WERE OBTAINED ON ONE PT WHILE USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THERE WERE NO INSTRUMENT GENERATED FLAGS WITH THE TEST RESULTS. THE INITIAL AND RETEST AUTOMATED RETICULOCYTE TEST RESULTS WERE DISCREPANT. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO THE MANUAL RETICULOCYTE TEST RESULTS, WHICH WERE HIGHER. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 DA