BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO® SYNCHRON CLINICAL SYSTEM

    MDR report key: 2083755 · Received May 10, 2011

    Report

    Report Number
    2050012-2011-01599
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION INFORMATION WERE NOT PROVIDED. QC INFORMATION WAS NOT PROVIDED. CUSTOMER STATED THAT THEY RESOLVED THE ISSUE BY ADJUSTING THE LAB ROOM TEMPERATURE. BCI SERVICE SUSPECTED CONTAMINATION AND DECONTAMINATED SYSTEM. SERVICE INDICATED THAT THE DRIFT WAS RELATED TO THE LAB'S AIR CONDITIONING. AS OF 04/25/2011, THE CUSTOMER DID NOT REPORT ANY ADDITIONAL ION-SELECTIVE ELECTRODE (ISE) ISSUES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE UNICEL DXC 600 PRO INSTRUMENT GENERATED HIGH NA, K, AND CL RESULTS FOR ONE (1) PATIENT. RESULTS WERE REPORTED OUT OF THE LAB AND WERE QUESTIONED BY PHYSICIANS. THE CUSTOMER DID NOT PROVIDE ANY OTHER DETAILS AND IT IS UNKNOWN IF RESULTS WERE AMENDED. THE MAGNITUDE OF ERROR IS UNKNOWN. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL DATA. THE CUSTOMER DID NOT SUPPLY ANY ADDITIONAL DATA. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO® SYNCHRON CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1