BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DCX 600I SYNCHRON ACCESS CLINICAL SYSTEM

    MDR report key: 2202540 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04223
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 19, 2008
    Report Date
    June 19, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGZ
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPLACED THE CL ELECTRODE TIP AND TOOK A CULTURE OF THE ION SPECIFIC ELECTRODE (ISE) SYSTEM AT THE POTASSIUM ELECTRODE PORT. THE CULTURE WAS FOUND TO BE NEGATIVE FOR BACTERIA. A BCI FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND DECONTAMINATED THE FLOW CELL. A CLEAR ROOT CAUSE HAS NOT BEEN IDENTIFIED FOR THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 2 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 2050012-2011-04224.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT THAT THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GAVE ERRONEOUSLY LOW CHLORIDE (CL) RESULTS FOR TWO PATIENTS. THE RESULTS WERE REPORTED OUT OF THE LAB. IT IS UNKNOWN IF THERE WERE ANY CHANGES TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT, HOWEVER THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY. CALIBRATION AND QUALITY CONTROLS (QC) ARE ROUTINELY RUN EVERY 24 HOURS BY THE NIGHT SHIFT. IN THE MORNING, THE OPERATOR NOTICED THAT THE CL QC RUN EARLIER HAD RECOVERED ON THE HIGH SIDE. CALIBRATION AND QC WERE REPEATED. THE CL RESULTS WERE LOWER. ALL CL SAMPLES RUN SINCE THE PREVIOUS CALIBRATION WERE REPEATED. ALL OF THE RESULTS CORRELATED EXCEPT RESULTS ON TWO SAMPLES WERE HIGHER. THE ORIGINAL "NORMAL" RESULTS WERE ACCEPTED AND REPORTED. BECAUSE OF THE ERRATIC QC RESULTS, CL WAS CALIBRATED AGAIN AND THE TWO DISCREPANT SAMPLES WERE RERUN. THE RESULTS MATCHED THE SECOND, HIGH RESULTS AND WERE CONFIRMED ON THE LAB'S SECOND ANALYZER. AMENDED REPORTS WERE ISSUED. THIS IS REPORT 1 OF 2 MEDWATCH REPORTS FILED FOR THIS EVENT FOR PATIENT 1 OF 2 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DCX 600I SYNCHRON ACCESS CLINICAL SYSTEM CGZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK