BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX9 ALX CLINICAL SYSTEMS

    MDR report key: 1962100 · Received January 17, 2011

    Report

    Report Number
    2050012-2011-00176
    Event Type
    Malfunction
    Date Received
    January 17, 2011
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    CIC
    PMA / PMN Number
    K950958
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGE. QC POST THE EVENT WAS OUT OF RANGE LOW. THE CUSTOMER DETERMINED THAT A CLOT HAD BEEN ASPIRATED INTO THE PROBE. HOTLINE ASSISTED THE CUSTOMER IN REMOVING CLOT AND CLEARING THE PROBE. SERVICE WAS NOT DISPATCHED. THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW CALCIUM (CA) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE SAMPLES WERE REPEATED AND HIGHER RESULTS WERE OBTAINED. THE ERRONEOUS AND CORRECTED RESULTS ARE NOT AVAILABLE. THE CUSTOMER SUPPLIED ONE EXAMPLE OF THE CA RESULT OF 6.4 MG/DL AND REPEAT RESULT OF 8.0 MG/DL. PATIENT'S TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE ERRONEOUS LOW RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX9 ALX CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER CIC BECKMAN COULTER INC. CX9 ALX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1