BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1156115 · Received September 4, 2008

    Report

    Report Number
    2122870-2008-00270
    Event Type
    Other
    Date Received
    September 4, 2008
    Date of Event
    August 7, 2008
    Report Date
    September 4, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE TYPE WAS PLASMA LITHIUM HEPARIN. QC TESTED PRIOR TO AND FOLLOWING THE EVENT RESULTED WITHIN ESTABLISHED RANGES. CUSTOMER REPORTED TO CUSTOMER TECHNICAL SUPPORT (CTS) THAT NO ERRORS WERE POSTED TO THE EVENT LOG NEAR THE TIME OF EVENT. THE CUSTOMER ADMITTED TO CTS THAT THEY WERE A WEEK LATE IN PERFORMING WEEKLY MAINTENANCE. PER INSTRUMENT MANUAL, NOT PERFORMING WEEKLY MAINTENANCE PER RECOMMENDED SCHEDULE COULD LEAD TO DIRTY ASPIRATE PROBES WHICH MAY AFFECT THE QUALITY OF THE SYSTEM WASH FUNCTION. SERVICE WAS NOT DISPATCHED REGARDING THE EVENT AS SERVICE WAS DECLINED BY THE CUSTOMER. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED ACCUTNI RESULT GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. A PATIENT SAMPLE WAS TESTED FOR ACCUTNI AND A RESULT OF 0.56NG/ML WAS OBTAINED. UPON REPEAT THE NEXT DAY, THIS SAMPLE GAVE A RESULT OF 0.02NG/ML. A SECOND DRAW FROM THE PATIENT GAVE A "NORMAL" RESULT. THE ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY. THERE WAS NO EFFECT TO PATIENT OR USER WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA