BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER

    MDR report key: 931234 · Received October 22, 2007

    Report

    Report Number
    2050012-2007-00034
    Event Type
    Other
    Date Received
    October 22, 2007
    Date of Event
    August 12, 2007
    Report Date
    October 22, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT AVAILABLE. QC RUN ON THE DAY OF THE EVENT WAS ACCEPTABLE. (A) THE OPERATOR RAN QC AFTER THE ERRONEOUS RESULTS WERE OBTAINED, WHICH RECOVERED LOW ON ALL CARTRIDGE CHEMISTRIES. THE CUSTOMER CONTACTED HOTLINE IN 2007 AND WAS ASSISTED BY PHONE TO FLUSH OUT THE PROBES, BUT THE PROBLEM CONTINUED. THE LAB SUPERVISOR REQUESTED SERVICE ON THE NEXT DAY, AND AN ENGINEER WORKED WITH THE LABORATORY SUPERVISOR BY PHONE. (A) THE CUSTOMER WAS INSTRUCTED BY THE ENGINEER TO PERFORM ADDITIONAL FLUSHING OF THE SAMPLE PROBE AND THE PROBLEM WAS RESOLVED. BASED ON AVAILABLE INFORMATION, A PARTIALLY PLUGGED SAMPLE PROBE MAY HAVE CONTRIBUTED TO THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) REGARDING ERRONEOUSLY LOW CARTRIDGE CHEMISTRY RESULTS WHICH WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON INSTRUMENT. INITIAL PHENYTOIN (PHY) RESULT WAS "<2.5 UG/ML". THE CUSTOMER RE-TESTED THE ORIGINAL SAMPLE ON ANOTHER INSTRUMENT IN THEIR LAB AND OBTAINED RESULT OF 30 UG/ML. INITIAL MAGNESIUM (MG) RESULT WAS 0.0 MG/DL AND 2.1 MG/DL UPON REPEAT ON ANOTHER INSTRUMENT IN THE CUSTOMER'S LAB. ALL SAMPLES RUN SINCE THE PREVIOUS QC RUN WERE REPEATED ON ANOTHER INSTRUMENT IN THE CUSTOMER'S LAB AND CORRECTED REPORTS WERE ISSUED AS NECESSARY. THE CUSTOMER IS NOT AWARE OF ANY PATIENT TREATMENT BEING WITHHELD OR INITIATED BASED ON ERRONEOUSLY LOW RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC. DXC 800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR