BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 2165145 · Received July 17, 2011

    Report

    Report Number
    2050012-2011-02936
    Event Type
    Malfunction
    Date Received
    July 17, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DRAWN AND PROCESSED ACCORDING TO LABORATORY PROCEDURE. UPON EXAMINATION OF THE SAMPLE AFTER THE SAMPLE WAS FIRST PROCESSED, IT WAS DISCOVERED THAT THERE WERE MULTIPLE BUBBLES AT THE TOP OF THE SAMPLE. BCI LABELING INSTRUCTS CUSTOMERS TO ENSURE THERE ARE NO BUBBLES IN THE SAMPLE BEFORE PROCESSING. IN THE CUSTOMER'S LABORATORY, D-DIMER IS RUN USING THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM AND A UDR REAGENT. THE UDR REAGENT HAS NOT BEEN VALIDATED BY BCI. PRIOR TO THE EVENT, D-DIMER QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. AT THE TIME OF THE EVENT, THERE WERE NO OTHER CHEMISTRY ERRORS OR INSTRUMENT ERRORS. NO OTHER PATIENT SAMPLES OR RESULTS WERE AFFECTED. IT CANNOT BE DETERMINED IF THE ERROR WAS CAUSED BY POOR SAMPLE INTEGRITY AND/OR FAILURE OF THE SAMPLE PROBE LEVEL SENSE MECHANISM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING A D-DIMER RESULT OF 0 THAT WAS GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE LOW D-DIMER RESULT OF 0 WAS QUESTIONED AND NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO AFFECT TO PATIENT 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 JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1