BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER ACT 5 DIFF ANALYZER

    MDR report key: 1364057 · Received January 16, 2009

    Report

    Report Number
    1061932-2009-00001
    Event Type
    Other
    Date Received
    January 16, 2009
    Date of Event
    December 15, 2008
    Report Date
    January 16, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K003677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE DRAWN IN 4 ML EDTA VACUTAINERS AND ANALYZED THE SAME DAY. QC IS RUN DAILY AND THE INSTRUMENT RECOVERED WITHIN QC SPECIFICATIONS. THE FIELD SERVICE ENGINEER (FSE) CONFIRMED THE PROBLEM BY RUNNING REPRODUCIBILITY. THE FSE REBUILT THE SAMPLE AND REAGENT SYRINGES, CHECKED TRAVERSE BELT TENSION, LUBED RAILS, ADJUSTED CARRIAGE STOP COLLAR, CHECKED PROBE ALIGNMENT, AND VERIFIED CONDITION OF PROBE. AS OF 2009, NO FURTHER LOW/ERRATIC RESULTS HAVE BEEN REPORTED. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED TO DATE FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW PLATELET (PLT) AND HEMOGLOBIN (HGB) RESULTS PRODUCED BY THE COULTER ACT 5 DIFF ANALYZER. SEVERAL PT SAMPLES WERE TESTED FOR PLT AND GAVE RESULTS IN THE RANGE OF 121 - 320 X 10^3 CELLS/ML. THESE SAMPLES WERE ALSO TESTED FOR HGB AND GAVE RESULTS IN THE RANGE OF 8.7 - 16.8G/DL. SAMPLE ONE WHEN TESTED ON THE COULTER ACT 5 DIFF ANALYZER GAVE A PLT RESULT OF 144 X 10 TO THE THIRD POWER CELLS/ML AND AN HGB RESULT OF 10.2G/DL. IT WAS TESTED IN A REFERENCE LAB UPON WHICH IT GAVE A PLT RESULT OF 189 X 10^3 CELLS/ML AND A HGB RESULT OF 13.2G/DL WHICH WERE CONSIDERED CORRECT. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. IT IS UNK IF THERE WAS AN AFFECT TO PT OR USER WITH REGARDS TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER ACT 5 DIFF ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. ACT 5 DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA