BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS

    MDR report key: 1953325 · Received January 7, 2011

    Report

    Report Number
    2050012-2011-00061
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    September 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ION-SELECTIVE ELECTRODE (ISE) SYSTEM IS CALIBRATED EVERY 24 HOURS. ISE QC SAMPLES ARE RUN EVERY 8 HOURS. QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. UNDER THE DIRECTION OF THE HOTLINE, THE CUSTOMER CONFIRMED SEEING BUBBLE IN THE RATIO PUMP ON THE FIRST PRIME CYCLE. A FIELD SERVICE ENGINEER (FSE) COMPLETED ISE PREVENTATIVE MAINTENANCE (PM) WHICH INCLUDED: BLEACHING THE ISE SYSTEM REPLACING ALL ISE TUBING, CARBON BRIDGE, AND ELECTROLYTE INJECTION CUP (EIC) SEALS REBUILDING THE RATIO PUMP. NO FURTHER CALLS HAVE BEEN MADE TO THE BCI HOTLINE IN REGARDS TO THE ISE PROBLEMS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS WITHIN THE DATE RANGE (B)(6) 2010 - (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS/OCCURRENCES. THIS REPORTABLE EVENT IS RELATED TO PREVIOUSLY SUBMITTED MDR 2050012-2010-00974.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUS HIGH SODIUM (NA), POTASSIUM (K), CHLORIDE (CL), CARBON DIOXIDE (CO2), AND CALCIUM (CA) RESULTS GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE SAMPLE WAS REPEATED AND LOWER ISE RESULTS WERE OBTAINED. ALL RESULTS OF ELECTROLYTES IN THIS LAB WERE GENERATED FROM SYSTEM ID (B)(4) AND (B)(4). SYSTEM ID (B)(4) IS CAPTURED IN MDR 2050012-2010-00974. PATIENT TREATMENT WAS NOT IMPACTED BY THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON UNICEL DXC 800 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. DXC 800 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1