BEUDAMED
    FDA Adverse Event Other Summary report: N

    FC 500 WITH RXP SW V1.0

    MDR report key: 528469 · Received February 6, 2004

    Report

    Report Number
    1061932-2004-00001
    Event Type
    Other
    Date Received
    February 6, 2004
    Date of Event
    January 8, 2004
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    LXG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CALLED BECKMAN COULTER REGARDING DISCORDANT SAMPLE IDS AND RUN DATES. THE DISCREPANCY BETWEEN THE CORRECT SAMPLE IDS AND TEST DATES WERE IDENTIFIED ON 5 SAMPLES WHEN THE TEST DATA WAS COMPARED WITH THE LEGEND PLOT WHILE RUNNING A CUSTOMER CREATED PROTOCOL (FLOWPAGE). THE LEGEND PLOT CONTAINED FCS KEYWORDS TO IDENTIFY RUNTIME INFO/IDENTIFICATION. THE ON SCREEN DATE (FLOWPAGE) FOR THE SAMPLE ID FIELD INDICATED THE SAMPLE ID WAS "755 VAL HBG ABCT". THE SAMPLE ID FIELD IS AN AUTO-FILL FIELD. THE ON SCREEN DATA (FLOWPAGE) FOR THE RUN DATE FIELD GENERATED A FIXED DATE OF 1/2004. THE RUN DATE FIELD IS THE TEST DATE OF THE SAMPLE BEING TESTED (1/2004). NO INCORRECT RESULTS WERE RELEASED OUT OF THE LAB. THE LEGEND PLOT (USED TO INTERPRET THE RESULTS) CONTAINED THE CORRECT SAMPLE ID AND RUN DATE. THERE WAS NO NEGATIVE CLINICAL OUTCOME TO THE PT. THE SAMPLES USED WITH THIS PROTOCOL WERE PART OF AN INTERNAL VALIDATION STUDY AND WERE NOT REPORTED OUT OF THE LAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FC 500 WITH RXP SW V1.0 GENERAL PURPOSE LAB EQUIPMENT LABELED OR PROMOTED FOR A SPEC LXG BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other