BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEMS

    MDR report key: 2250854 · Received September 16, 2011

    Report

    Report Number
    2050012-2011-05337
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NA QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES, BUT THE HIGH LEVEL CONTROL WAS AT THE VERY LOW END OF THE CUSTOMER'S RANGE. CL QC PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES, BUT THE HIGH LEVEL CONTROL WAS AT THE VERY HIGH END OF THE CUSTOMER'S RANGE. BEC FIELD SERVICE ENGINEER (FSE) REPLACED THE CL ELECTRODE BODY SINCE THE PROTECTIVE SHEATH WAS PULLED BACK. THE FSE ALSO REPLACED THE CARBON BRIDGE AND VERIFIED PERFORMANCE. ALTHOUGH THE FSE REPLACED PARTS, THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM GENERATED ONE (1) LOW SODIUM (NA) AND ONE (1) HIGH CHLORIDE (CL) RESULTS FOR TWO (2) DIFFERENT PATIENTS. THE RESULTS WERE NOT REPORTED OUT OF THE LAB. PATIENT SAMPLES WERE RETESTED ON A DIFFERENT INSTRUMENT IN THE LAB AND THOSE RESULTS WERE REPORTED. THERE WAS NOT AN EFFECT TO PATIENT OR USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1