BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER AC-T DIFF 2 HEMATOLOGY ANALYZER

    MDR report key: 490720 · Received October 14, 2003

    Report

    Report Number
    1061932-2003-00016
    Event Type
    Other
    Date Received
    October 14, 2003
    Date of Event
    August 20, 2003
    Report Date
    October 14, 2003
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO CO'S CUSTOMER, DURING A ROUTINE QC PROCEDURE IN THE AFTERNOON, THEY NOTICED THE AC-T DIFF2 INSTRUMENT GENERATING A HIGH PLATELET RESULT. THE PLATELET BACKGROUND RESULT WAS HIGH OUT OF RANGE IN THE AFTERNOON [>140 X 103 CELLS/UL]. THE PLATELET CONTROL VALUES FOR THE AFTERNOON WERE HIGH OUT OF RANGE. THE CUSTOMER SUSPECTS THAT SAMPLE RESULTS MAY HAVE BEEN REPORTED DURING THIS TIME. NO PT INFO/RESULTS WERE PROVIDED BY THE CUSTOMER. THERE HAS BEEN NO CHANGE TO PT TREATMENT THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER AC-T DIFF 2 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKH BECKMAN COULTER, INC. AC-T DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other