BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2201993 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04147
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    April 8, 2008
    Report Date
    April 9, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE LAB AND DISCOVERED EVIDENCE OF A PREVIOUS FLOW CELL LEAK. THE FSE ALSO FOUND DEBRIS AND FIBRIN IN THE ELECTRODE PORTS. THE FLOW CELL WAS DISMANTLED AND CLEANED. THE CUSTOMER WAS PROVIDED WITH A NEW FLOW CELL WEEKLY CLEANING PROCEDURE USING 10% ACETIC ACID. THE LAB HAS ADDED A PT SERUM CONTROL TO THEIR PROCEDURE. BASED ON THE AVAILABLE INFO, A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6), 2008 AND (B)(6), 2010 FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 6 OF 25 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: 2050012-2011-04142, 04143, 04144, 04145, 04146, 04148, 04149, 04150, 04151, 04152, 04153, 04154, 04155, 04156, 04157, 04158, 04159, 04160, 04161, 04162, 04163, 04164, 04165, 04166.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM GAVE ERRONEOUSLY LOW SODIUM (NA) RESULTS FOR MULTIPLE PATIENTS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB AND SOME PATIENTS WERE INCORRECTLY ADMITTED. THE ERRONEOUS RESULTS OCCURRED IN THE MIDDLE OF A RUN, AFTER THE SYSTEM WAS CALIBRATED AND A QUALITY CONTROL (QC) WAS COMPLETED. THE QC RECOVERED WITHIN THE LAB'S ESTABLISHED RANGES. WHEN THE ERRONEOUS RESULTS WERE DISCOVERED, THE LAB REPEATED ALL OF THE SAMPLES RUN SINCE THE PREVIOUS QC. THE CUSTOMER STATED THAT ABOUT 25 CORRECTED REPORTS WERE ISSUED. NO PT INFO WAS PROVIDED BY THE CUSTOMER. SAMPLES ARE DRAWN INTO BECTON DICKENSON LITHIUM HEPARIN PLASMA SEPARATOR TUBES. THIS IS REPORT 6 OF 25 MEDWATCH REPORTS FILED FOR THIS EVENT FOR PT 6 OF 25 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON CLINICAL SYSTEM JGS BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization