BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER AC T 5 DIFF ANALYZER

    MDR report key: 622985 · Received July 25, 2005

    Report

    Report Number
    1061932-2005-00025
    Event Type
    Other
    Date Received
    July 25, 2005
    Date of Event
    June 29, 2005
    Report Date
    July 25, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING INCONSISTENT HGB, RBC, AND PLATELET (PLT) RESULTS ON CAPILLARY SAMPLES THAT WERE GENERATED BY THE COULTER AC T 5 DIFF INSTRUMENT. THE CUSTOMER PROVIDED RESULTS FROM ONLY ONE (1) PT. THE INITIAL RESULTS WERE: HGB 125G/L, RBC 4.34 X 10(12)/L, AND PLT 357 X 10(9)/L. THE CUSTOMER RE-TESTED THE PT ORIGINAL SAMPLE FOR ALL 3 PARAMETERS. THE REPEATED RESULTS WERE: HGB 37G/L, RBC 1.27 X 10(12)/L AND PLT 118 X 10(9)/L. THE CUSTOMER RE-TESTED THE PT ORIGINAL SAMPLE 2ND TIME ABD OBTAINED RESULTS AS FOLLOWS: HGB 125G/L, RBC 4.42 X 10(12)/L, AND PLT 325 X 10(9)/L. THE CUSTOMER INDICATED THAT THERE WAS NO CHANGE IN PT TREATMENT THAT CAN BE ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other