BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1200384 · Received October 15, 2008

    Report

    Report Number
    2122870-2008-00321
    Event Type
    Other
    Date Received
    October 15, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLES WERE DRAWN IN BD LIHEP TUBES. PER CUSTOMER, INITIAL SAMPLE WAS RUN ON A BARCODED, PRIMARY TUBE THROUGH AUTOMATED CTA (CLOSED TUBE ACCESSING SYSTEM). RERUN WAS PERFORMED ON ANOTHER TUBE FROM THE SAME DRAW TIME. A PM (PREVENTIVE MAINTENANCE) WAS RECENTLY PERFORMED AND PER CUSTOMER, ALL QC AND SYSTEM CHECKS HAVE BEEN PERFORMING ACCORDING TO SPECIFICATIONS. A PRECISION RUN WAS ALSO PERFORMED AND WAS ACCEPTABLE TO CUSTOMER. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. 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 PRODUCED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM FOR ONE PATIENT. CUSTOMER TESTED A PATIENT SAMPLE FOR ACCUTNI AND OBTAINED A RESULT OF 21.47NG/ML. A SECOND SAMPLE FROM THE SAME DRAW AS THE FIRST SAMPLE GAVE A RESULT OF 0.03NG/ML. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO AFFECT TO PATIENT OR USER WITH REGARDS 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 JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA