BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 1992588 · Received February 15, 2011

    Report

    Report Number
    2122870-2011-00373
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    MMI
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN LITHIUM HEPARIN GEL SEPARATOR TUBES. QC DATA NOT PROVIDED SERVICE WAS NOT DISPATCHED PER CUSTOMER, THE UNIT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO A NON REPRODUCIBLE FALSE POSITIVE ACCUTNI RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS2 CLINICAL SYSTEM. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE CUSTOMER, VIA TELEPHONE, PROVIDED ONE EXAMPLE OF AN EVENT WHERE AN ELEVATED ACCUTNI PATIENT RESULT INITIALLY RECOVERED WITHIN THE RISK STRATIFICATION RANGE ON A PATIENTS' SAMPLE. UPON REPEAT, ON THE SAME UNIT, THE RESULT RECOVERED WAS WITHIN THE NORMAL REFERENCE RANGE. PATIENT DATA FOR THIS EVENT WAS NOT SUPPLIED. THE CUSTOMER DID NOT REPORT AFFECT TO THE PATIENT OR USER ATTRIBUTED OR CONNECTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM CLINICAL CHEMISTRY SYSTEMS MMI BECKMAN COULTER INC. ACCESS 2 DXC600I N/A

    Patients

    Seq Age Sex Outcome Treatment
    1