BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750

    MDR report key: 537553 · Received March 16, 2004

    Report

    Report Number
    1061932-2004-00002
    Event Type
    Other
    Date Received
    March 16, 2004
    Date of Event
    February 12, 2004
    Report Date
    March 12, 2004
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, AN INCORRECT PLATELET RESULT WAS GENERATED BY AN LH 750 INSTRUMENT. THE INCORRECT PLATELET RESULT WAS 592,000 CELLS/ML. THE INCORRECT PLATELET RESULT WAS REPORTED OUT OF THE LAB. THE CUSTOMER INDICATED THAT THIS RESULT WAS DETERMINED TO BE INCORRECT AFTER THE MANUAL SLIDE REVIEW DID NOT AGREE WITH THE PLATELET RESULT FROM THE LH750. THE MANUAL PLATELET COUNT PROVIDED A PLATELET ESTIMATE OF 79,000 CELLS/ML. DUE TO THE DISCORDANT PLATELET RESULTS (BETWEEN THE LH750 AND THE MANUAL SLIDE REVIEW); THE LAB RETESTED THE ORIGINAL PT SAMPLE USING A DIFFERENT HEMATOLOGY ANALYZER. THE PT SAMPLE WAS VORTEXED PRIOR TO RETESTING. THE CUSTOMER INDICATED THAT VORTEXING A PT SAMPLE FOR 1-2 MINUTES IS PART OF THEIR LAB PROTOCOL TO ENSURE BREAK UP OF PLATELET CLUMPS. THE REPEATED PLATELET RESULT WAS 89,000 CELLS/ML. THIS RESULT WAS ACCEPTED BY THE CUSTOMER SINCE IT CORRELATED WELL WITH THE MANUAL SLIDE REVIEW COUNT. ALSO, THIS RESULT CORRELATED WELL WITH THE PT'S PREVIOUS PLATELET RESULT OF 87,000 CELLS/ML FROM 2/2004. CORRECTED PLATELET RESULTS WERE SENT TO THE PT'S CHART AFTER DISCOVERY OF THE INCORRECT PLATELET RESULTS. BASED ON THE INFO PROVIDED BY THE CUSTOMER, THERE WAS 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 LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other