BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T DIFF 2 ANALYZER

    MDR report key: 1894399 · Received November 9, 2010

    Report

    Report Number
    1061932-2010-00207
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 11, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990312
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A 4ML BD VACUTAINER TUBE. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). ON (B)(4) 2010 A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE WBC APERTURE AND THE ANALYZER MAIN CARD WITH NO RESOLUTION. ON (B)(4) 2010 THE FSE RETURNED AND REPLACED THE LYSE PUMP AND ASSOCIATED TUBINGS, THEN VERIFIED THE INSTRUMENTS OPERATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING THE COULTER ACT DIFF 2 ANALYZER WAS GENERATING ERRONEOUS WHITE BLOOD COUNT (WBC) AND DIFFERENTIAL RESULTS FOR ONE SPECIMEN WITH AND WITHOUT INSTRUMENT FLAGS. THE OPERATOR RERAN THE SAME SPECIMEN SEVERAL TIMES AND RECOVERED ERRATIC RESULTS FOR WBC AND DIFFERENTIAL PARAMETERS. THE CUSTOMER DID NOT PERFORM MANUAL COUNTS FOR COMPLETE BLOOD COUNT (CBC) PARAMETERS. THE CUSTOMER COULD NOT PROVIDE CORRECT RESULTS FOR WBC OR DIFFERENTIAL PARAMETERS. THE CUSTOMER CONSIDERS ALL WBC AND DIFFERENTIAL RESULTS ON THIS SPECIMEN TO BE INCORRECT AND DID NOT REPORT THESE RESULTS. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC*T DIFF 2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. ACT DIFF 2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1