BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2232154 · Received September 2, 2011

    Report

    Report Number
    1061932-2011-01320
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. INVESTIGATION OF THIS ISSUE IS ON-GOING. A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 1061932-2011-01316, 1061932-2011-01317, 1061932-2011-01318, 1061932-2011-01319, 1061932-2011-01320, 1061932-2011-01321, 1061932-2011-01322, 1061932-2011-01323, 1061932-2011-01353, 1061932-2011-01324, 1061932-2011-01325, 1061932-2011-01354, 1061932-2011-01326, 1061932-2011-01355.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT INCORRECTLY STATED THAT FOUR ADDITIONAL PATIENT SAMPLES POSSESSED QUESTIONABLE PLATELET RESULTS HOWEVER WERE CORRECTLY FLAGGED WITH R FLAGS AND PLATELET CLUMP MESSAGES BY THE INSTRUMENT. IN REALITY ONLY THREE ADDITIONAL PATIENT SAMPLES POSSESSED QUESTIONABLE PLATELET RESULTS HOWEVER WERE CORRECTLY FLAGGED WITH R FLAGS AND PLATELET CLUMP MESSAGES BY THE INSTRUMENT.

    Description of Event or Problem · 1

    THREE ADDITIONAL PATIENT SAMPLES POSSESSED QUESTIONABLE PLATELET RESULTS HOWEVER WERE CORRECTLY FLAGGED WITH R FLAGS AND PLATELET CLUMP MESSAGES BY THE INSTRUMENT. THE R FLAG INDICATED THAT RESULTS ARE QUESTIONABLE AND THE PLATELET CLUMP NOTIFICATION INDICATES THE PRESENCE OF PLATELET CLUMPS IN THE SAMPLE. BECAUSE THE RESULTS WERE APPROPRIATELY FLAGGED THESE RESULTS WERE NOT REGARDED AS ERRONEOUS..

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS PLATELET (PLT) COUNT RESULTS WITH NO INSTRUMENT FLAGS WERE GENERATED ON ONE OF TWO UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEMS FOR FOURTEEN PATIENTS OVER MULTIPLE DAYS. THIS IS REPORT EIGHT OF FOURTEEN AND REPRESENTS THE ERRONEOUS PLT RESULTS GENERATED ON THE UNICEL DXC 800 COULTER CELLULAR ANALYSIS SYSTEM WITH SERIAL NUMBER (B)(4) FOR ONE PATIENT SAMPLE ON (B)(6) 2011. THE PLT RESULT WAS REGARDED AS ERRONEOUS BECAUSE THE WHITE BLOOD COUNT (WBC) AND/OR PLT HISTOGRAM REVEALED INTERFERENCE AND PLATELET CLUMPS WERE PRESENT IN THE SAMPLE'S MANUAL SMEAR HOWEVER, NO INSTRUMENT ERROR FLAGS WERE INITIATED BY THE INSTRUMENT TO ADDRESS THE LOW PLT RESULT OR PRESENCE OF CLUMPS/INTERFERENCE. THE ERRONEOUS PLT RESULT WAS NOT RELEASED FROM THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT CONTROLS WERE RECOVERING WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THE EVENT. NO SPECIFIC PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. RAW DATA WAS NOT PROVIDED FOR ALL PATIENT SAMPLE RESULTS ASSOCIATED WITH THIS EVENT. FOUR ADDITIONAL PATIENT SAMPLES POSSESSED QUESTIONABLE PLATELET RESULTS HOWEVER WERE CORRECTLY FLAGGED WITH R FLAGS AND PLATELET CLUMP MESSAGES BY THE INSTRUMENT. THE R FLAG INDICATED THAT RESULTS ARE QUESTIONABLE AND THE PLATELET CLUMP NOTIFICATION INDICATES THE PRESENCE OF PLATELET CLUMPS IN THE SAMPLE. BECAUSE THE RESULTS WERE APPROPRIATELY FLAGGED THESE RESULTS WERE NOT REGARDED AS ERRONEOUS.

    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. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR