BEUDAMED
    FDA Adverse Event Other Summary report: N

    POWER PROCESSOR WITH LX CONNECTIONS

    MDR report key: 580354 · Received March 11, 2005

    Report

    Report Number
    2050012-2005-00009
    Event Type
    Other
    Date Received
    March 11, 2005
    Date of Event
    February 18, 2005
    Report Date
    March 9, 2005
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LXG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN EVENT WITH POWER PROCESSOR. THE EVENT OCCURRED WHEN CUSTOMER REUSED SAMPLE IDS AND TUBE WAS PROCESSED BY THE POWER PROC ESSOR (WITH LX CONNECTIONS FOR USE WITH THE SYNCHRON LX20). THE CUSTOMER DOWNLOADED A TEST REQUEST TO A PREPLINK (SAMPLE PROGRAMMING COMPUTER) FROM LIS (LAB INFORMATION SYSTEM). A PT SAMPLE WITH THE SAME SMAPLE I.D. WAS IN THE SYSTEM ALREADY (SINCE 02/05), AND CURRENTLY WAS IN A STOCKYARD STORAGE AT THE TIME OF THE EVENT. THE POWER PROCESSOR RETRIEVED THE INCORRECT SAMPLE FROM THE STOCKYARD STORAGE, AND SUBMITTED FOR TESTING. DUE TO REUSING OF SAMPLE IDS, 1 TUBE WAS RECALLED INCORRECTLY FROM SAME SAMPLE ID AS THE NEW TUBE WAS ASSAYED INSTEAD OF THE NEW TUBE. THE RESULTS FROM THE ORIGINAL SAMPLE TUBE WERE NOT REPORTED OUT OF THE LAB; THE DISCREPANCY WAS NOTED DURING THE SAMPLE VERIFICATION. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL INFO REGARDING THIS EVENT. THE CUSTOMER INDICATED THAT THE PT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER PROCESSOR WITH LX CONNECTIONS LAB AUTOMATION LXG BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other