BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC PRO SYNCHRON CLINICAL SYSTEMS

    MDR report key: 983318 · Received January 22, 2008

    Report

    Report Number
    2050012-2008-00004
    Event Type
    Malfunction
    Date Received
    January 22, 2008
    Date of Event
    December 24, 2007
    Report Date
    January 22, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, QC HAS BEEN ACCEPTABLE. A FIELD SERVICE ENGINEER (FSE) WAS NOT DISPATCHED TO THE CUSTOMER'S LAB, AS THE DISCREPANCY IS SUSPECTED TO BE A SAMPLE SPECIFIC. THERE IS NO SAMPLE AVAILABLE FOR BECKMAN COULTER INC (BCI) INVESTIGATION AT THIS TIME. CUSTOMER IS CONTINUING TO SCREEN SAMPLES AND WILL SAVE ANY ADD'L DISCREPANT SAMPLES FOR BCI INVESTIGATION. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR 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 FALSE LOW VANCOMYCIN (VANC) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CLINICAL SYSTEMS. THE CUSTOMER INDICATED THAT VANC RESULTS FOR 2 PT SAMPLES WERE LOWER ON THE UNICEL DXC INSTRUMENT WHEN COMPARED TO THE REFERENCE LAB RESULTS. THE CUSTOMER SENT APPROX 30 OTHER SAMPLES TO THE REFERENCE LAB FOR VANC VERIFICATION AND RESULTS RECOVERED COMPARABLY TO THE BCI RESULTS. NO ADD'L INFO REGARDING THIS EVENT IS AVAILABLE. IT IS UNK IF TREATMENT WAS INITIATED OR WITHHELD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA