BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 600 SYNCHRON SYSTEM

    MDR report key: 2493642 · Received March 15, 2012

    Report

    Report Number
    2050012-2012-00764
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 22, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    CGZ
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(4) 2012 CUSTOMER REPORTED THAT THE DXC 600 PRO INSTRUMENT GENERATED LOW CHLORIDE (CL) RESULTS ON 7 PATIENT SAMPLES. RESULTS WERE REPORTED OUT OF THE LAB. WHEN THE NURSING HOME QUESTIONED THE RESULTS, THE SAMPLES WERE REPEATED AND THE REPORTS AMENDED. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE ORIGINAL RESULTS REPORTED. QUALITY CONTROL PRIOR TO THE EVENT WAS WITHIN LAB-ESTABLISHED RANGES, BUT ON THE LOW SIDE OF THE RANGE. FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND A TORN ELECTROLYTE INJECTION CUP (EIC) VALVE AND A DIRTY CO2 PORT. FSE CLEANED THE FLOWCELL AND REPLACED THE VALVE AND SYRINGE. THIS RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 600 SYNCHRON SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE CGZ BECKMAN COULTER, INC. DXC 600 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1