BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 1943154 · Received December 30, 2010

    Report

    Report Number
    1061932-2010-00330
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    November 27, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THIS EVENT. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). PER THE CUSTOMER, RAW DATA ANALYSIS REVEALED THAT WBC CORRECTION WAS PERFORMED USING DEBRIS AS DETECTED. THE NRBC MODULE ALSO DETECTED THE SAME INTERFERENCE TO THE WBC COUNT. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT AND PERFORMED ALIGNMENTS AS NEEDED FOR BACKGROUND ISSUES AND VERIFIED THE INSTRUMENT OPERATION. PER BCI LABELING, NRBC'S ARE A KNOWN INTERFERING SUBSTANCE FOR WBC PARAMETER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING ERRONEOUSLY HIGH WHITE BLOOD COUNT (WBC) AND LOW NUCLEATED RED BLOOD COUNT (NRBC) RESULTS ON A NEWBORN INFANT THREE (3) TIMES OVER A THREE (3) DAY PERIOD THAT WERE GENERATED BY THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY ON THE FIRST TWO DAY'S RESULTS. A MANUAL SMEAR WAS REVIEWED ON (B)(6) 2010, PRODUCING SIGNIFICANTLY LOWER WBC RESULTS AND HIGHER NRBC RESULTS. VERY LARGE NRBC CELLS WERE SEEN ON THE MANUALLY PREPARED SLIDE. A CORRECTED REPORT WAS ISSUED. THE RESULTS FOR THE FIRST DAY ((B)(6) 2010) AND THE MANUAL SMEAR RESULTS WERE PROVIDED BY THE CUSTOMER. THERE WAS NO DEATH TO THE PATIENT; HOWEVER, THE PATIENT WAS ADMINISTERED ANTIBIOTICS DUE TO THE FALSE RESULTS. THE FOLLOWING REPORTS ARE ALSO LINKED TO THIS EVENT TO DOCUMENT THE ERRONEOUS RESULTS OBTAINED ON (B)(6) 2010, RESPECTIVELY: 1061932-2010-00331 AND 1061932-2010-00332

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other