BEUDAMED
    FDA Adverse Event Other Summary report: N

    CELL-DYN 4000 110V

    MDR report key: 1022520 · Received March 24, 2008

    Report

    Report Number
    2919069-2008-00477
    Event Type
    Other
    Date Received
    March 24, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K961439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (INVESTIGATION PENDING). THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE ACCOUNT NOTICED WBC IMPRECISION WITH THE CELL-DYN 4000 ANALYZER. ONE PT GENERATED A WBC = 3000/UL BUT WHEN THE SPECIMEN WAS TESTED ON ANOTHER ANALYZER THE WBC = 9000 (NO UNITS OF MEASUREMENT WERE GIVEN). THE WBC = 3000/UL WAS NOT REPORTED OUTSIDE OF THE LAB. THROUGH TROUBLESHOOTING, IT WAS DISCOVERED THAT WBC IMPRECISION HAD BEEN OCCURRING FOR THE PREVIOUS 2 HOURS AND ABOUT 50 PT SPECIMENS WERE REPORTED WITH INACCURATE RESULTS. THE 50 SPECIMENTS WERE RERUN AND THE REPORTS WERE CORRECTED. NO SPECIFIC PT INFO OR DATA IS AVAILABLE. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 4000 110V AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI