BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCHRON LXI 725 CLINICAL SYSTEM

    MDR report key: 481743 · Received August 29, 2003

    Report

    Report Number
    2050012-2003-00017
    Event Type
    Other
    Date Received
    August 29, 2003
    Date of Event
    July 31, 2003
    Report Date
    August 29, 2003
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BASED ON INFO OBTAINED FROM THE CUSTOMER IN 2003, AN ERRONEOUSLY ELEVATED ACCU TNI RESULT OF 6.18 NG/ML WAS GENERATED BY SYNCHRON LXI SYSTEM. THE ERRONEOUSLY ELEVATED RESULT WAS REPORTED OUT OF THE LAB IN JULY 2003. THE FLOOR QUESTIONED THE ACCU TNI RESULT AND THE CUSTOMER RERAN THE PT SAMPLE USING THE IMMUNOCHEMISTRY ANALYZER COMPONENT (INDEPENDENT MODE) OF THE SYNCHRON LXI SYSTEM. THE REPEATED ACCU TNI RESULT WAS 0.0.8 NG/ML. THE RESULT OF 0.08 NG/ML WAS REPORTED OUT OF THE LAB. THE PT WAS REDRAWN IN 2003 AT 0252 FOR ACCU TNI. THE SAMPLE WAS RUN USING THE IMMUNOCHEMISTRY ANALYZER COMPONENT (INDEPENDETN MODE) OF THE SNCHRON LXI SYSTEM. THE SCCU TNI RESULT WAS 0.06 NG/ML. 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 SYNCHRON LXI 725 CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. NONE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other