BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF2 ANALYZER

    MDR report key: 2283643 · Received October 7, 2011

    Report

    Report Number
    1061932-2011-01644
    Event Type
    Malfunction
    Date Received
    October 7, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 8, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS RUN BEFORE THE EVENT SHOWED MCV RESULTS ON A POSITIVE BIAS BUT WITHIN RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND FOUND THE MCV RECOVERY ON THE HIGH END OF THE QUALITY CONTROL RANGE (WITHIN SPECIFICATIONS). REPRODUCIBILITY WAS PERFORMED USING THE NORMAL CONTROL AND MCV WAS ADJUSTED DOWN. THE CUSTOMER WAS SENT AN S-CAL CALIBRATION KIT AND WILL CALIBRATE ONCE THE KIT IS RECEIVED. THE ROOT CAUSE FOR THE HIGH MCV RESULT CAN BE ATTRIBUTED TO A POSITIVE QC BIAS AND THE FAILED MCV CALIBRATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REGARDING A HIGH MCV RESULT OF 85.7FL WITHOUT INSTRUMENT FLAGS GENERATED BY THE COULTER ACT DIFF2 ANALYZER FOR ONE PATIENT SAMPLE WHICH WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR TESTING AND RECOVERED A RESULT OF 79FL. THERE WAS NO AFFECT TO PATIENT WITH REGARD TO THIS EVENT. *COMPUTED: MCV=(HCT/RBC) X 10. MCV - MEAN CELL VOLUME CALCULATION. HCT - HEMATOCRIT. RBC - RED BLOOD CELL COUNT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT DIFF2 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. ACT DIFF2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1