BEUDAMED
    FDA Adverse Event Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2060514 · Received April 18, 2011

    Report

    Report Number
    2050012-2011-01197
    Date Received
    April 18, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED ION-SELECTIVE ELECTRODE (ISE) RESULTS WERE REQUESTED, HOWEVER THE RESULTS WERE NOT AVAILABLE. THE CUSTOMER INDICATED THE RESULTS WERE NORMAL WHEN RUN ON THE OTHER ANALYZER AND THAT THOSE RESULTS MATCHED PREVIOUS RESULTS. NO SAMPLE INFORMATION WAS PROVIDED. CALIBRATION AND QC WOULD NOT BE AFFECTED BY THIS ISSUE BECAUSE CALIBRATIONS AND QCS ARE RUN IN CUPS THAT ARE NOT CAP-PIERCED. A BCI FIELD SERVICE ENGINEER (FSE) PERFORMED THE FOLLOWING: REPLACED THE CAP PIERCER DRAIN VALVE, WICK & AUTOGLOSS DELIVERY TUBING. COMPLETED THE CAP PIERCER ALIGNMENTS. VERIFIED PROPER Z-CUT AND AUTOGLOSS DELIVERY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ERRONEOUS LOW ISE RESULTS DUE TO DILUTED WASH CONCENTRATE LEAK FORM THE SHOWER BLOCK (CAP PIERCER). NO INCORRECT RESULTS WERE REPORTED OUT OF THE LABORATORY. NO OPERATOR EXPOSURE TO THE DILUTE WASH SOLUTION WAS NOTED. NO AFFECT TO PATIENTS, THE INCORRECT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1