BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 1892894 · Received November 8, 2010

    Report

    Report Number
    2050012-2010-01185
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 20, 2010
    Report Date
    November 8, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISE SYSTEM IS ROUTINELY CALIBRATED EVERY 12 HOURS FOLLOWED BY A QC RUN. PRIOR TO THE EVENT, CO2 QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED: THE FSE BLEACHED THE FLOW CELL AND REPLACED THE CO2 ELECTRODE AND MEMBRANE. AS OF (B)(4) 2010, THERE WERE NO FURTHER CALLS TO HOTLINE FOR ISE PROBLEMS. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY LOW CARBON DIOXIDE (CO2) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEMS. THE LOW RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER RUN CO2 QC AND RESULTS WERE OUTSIDE >2SD LOW. THE LABORATORY MANAGER NOTIFIED THE MEDICAL STAFF THAT CO2 RESULTS REPORTED PREVIOUSLY THAT DAY WERE QUESTIONABLE AND TO NOT BASE MEDICAL DECISIONS ON THE RESULTS. THE ISE SYSTEM WAS RECALIBRATED AND QC SAMPLES WERE RUN. THE CO2 QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. ALL SAMPLES THAT HAD BEEN RUN SINCE THE PREVIOUS QC RUN WERE REPEATED. AMENDED RESULTS WERE ISSUED ON 14 PATIENT SAMPLES. NO PATIENTS WERE TREATED BASED ON THE FALSE CO2 RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1