BEUDAMED
    FDA Adverse Event Other Summary report: N

    DL2000

    MDR report key: 550433 · Received October 20, 2004

    Report

    Report Number
    2050012-2004-00026
    Event Type
    Other
    Date Received
    October 20, 2004
    Date of Event
    September 21, 2004
    Report Date
    October 20, 2004
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER TO REPORT THAT THE WRONG PT DEMOGRAPHICS HAD BEEN ASSOCIATED WITH A SAMPLE ID (A) AT THE DL2000 (DL) DATA MANAGER SYSTEM. THE CUSTOMER INDICATED THAT SAMPLE A WITH PT ID, PT NAME AND SAMPLE ID FOR A WAS DOWNLOADED FROM THEIR LIS TO THE DL2000. THE SAMPLE PROGRAMMING INFO WAS REJECTED BY DL2000 DUE TO INCOMPATIBLE TEST. THE SAMPLE TUBE (A) WAS LOADED ONTO THE INSTRUMENT BY THE CUSTOMER. THE CUSTOMER WAS NOT AWARE THAT THE DL2000 HAD REJECTED THE PROGRAMMING FOR SAMPLE A THE INSTRUMENT RAN TESTS (PREVIOUSLY ORDERED FOR THIS SAMPLE ID WITH DEMOGRAPHICS FROM B) ON SAMPLE A THAT WERE PENDING, BUT ASSOCIATED THEM WITH THE DEMOGRAPHICS FOR SAMPLE B THE SAMPLE ID FOR A (PREVIOUSLY LINKED TO DEMOGRPHICS FROM B) HAD TO BE PRESENTED AT EITHER THE DL2000 OR AT THE INSTRUMENT FOR THE SAMPLE TO BE RUN. THE INSTRUMENT UPLOADED THE SAMPLE RESULTS FOR SAMPLE A TO THE DL2000. SINCE THE SAMPLE ID WAS ASSOCIATED WITH DEMOGRAPHICS FROM B, THE DL2000 FILED THE RESULTS FOR SAMPLE A WITH SAMPLE B'S DEMOGRAPHICS, UPON UPLOAD TO THE LIS, THE RESULTS POSTED TO THE CORRECT DEMOGRAPHICS, AS DL2000 UPLOADS ONLY THE SAMPLE ID WITH THE RESULTS. THE LIS CORRECTLY MATCHED THE SAMPLE RESULTS FOR A WITH THE DEMOGRAPHICS FOR SAMPLE A ON FILE IN THE LIS. THE WRONG DEMOGRAPHICS WERE NOT REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DL2000 DATA MANAGEMENT SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other