BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 SYNCHRON® SYSTEM

    MDR report key: 3749752 · Received April 14, 2014

    Report

    Report Number
    2050012-2014-00200
    Event Type
    Malfunction
    Date Received
    April 14, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    MZV
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER WAS NOT DISPATCHED. THE CUSTOMER SUPPORT REPRESENTATIVE ASSISTED THE CUSTOMER OVER THE PHONE. THE CUSTOMER FOUND THE END OF LINE #24 (ISE BUFFER REAGENT) WAS NOT CONNECTED AT THE RATIO PUMP. THE CUSTOMER TRIMMED AND RECONNECTED THE LINE, RESOLVING THE ISSUE. (B)(4). CUSTOMER WAS ABLE TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEIR DXC 600 INSTRUMENT GENERATED FALSE HIGH K (POTASSIUM) AND CL (CHLORIDE) RESULTS FOR 3 PATIENT SAMPLES. NA (SODIUM), CO2 (CARBON DIOXIDE) AND CALC (CALCIUM) RESULTS WERE SUPPRESSED (NO RESULTS GENERATED) FOR THESE SAME SAMPLES. THE RESULTS WERE NOT REPORTED OUT OF THE LABORATORY SO THERE WAS NO IMPACT TO PATIENT TREATMENT. WHEN THE ISSUE WAS NOTICED, SAMPLES WERE REPEATED. IT IS UNKNOWN IF THE REPEATS WERE PERFORMED ON THE SAME OR ANOTHER INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227365 UNICEL® DXC 600 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MZV BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1