BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC T 5DIFF CP HEMATOLOGY ANALYZER

    MDR report key: 2242146 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01430
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHOLE BLOOD COLLECTED BY VENIPUNCTURE AT THE SAME FACILITY AND TESTED PROMPTLY CONTROLS RUN BEFORE THE INCIDENT RECOVERED WITHIN RANGE. THE ACT 5DIFF CP IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). THE CALL CENTER TECHNICAL REPRESENTATIVE REVIEWED THE DATA AND FOUND THE ERRONEOUS HIGH WBC RESULT HAD A V (VOTEOUT) FLAG AND THE RERUN WBC HAD NO FLAGS. THE ROOT CAUSE FOR THE ERRONEOUS RESULT IS UNKNOWN; HOWEVER, INSTRUMENT GENERATED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC (BEC) IN REGARDS TO ERRONEOUS HIGH WBC RESULTS WITHIN INSTRUMENT (COULTER AC T 5DIFF CP HEMATOLOGY ANALYZER) GENERATED FLAGS ON A SPECIFIC SAMPLE. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE RESULTS WERE QUESTIONED WHEN THE CUSTOMER RERAN THE SAMPLE PER DOCTOR'S ORDER AND RECOVERED A MUCH LOWER WBC THAN THE INITIAL RUN. THE CALL CENTER TECHNICAL REPRESENTATIVE REVIEWED THE DATA AND FOUND THE ERRONEOUS HIGH WBC RESULT HAD A "V" (VOTEOUT) FLAG AND THE RERUN WBC HAD NO FLAGS. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® AC T 5DIFF CP HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT 5DIFF CP N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR