BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 2060404 · Received April 16, 2011

    Report

    Report Number
    2050012-2011-01179
    Event Type
    Malfunction
    Date Received
    April 16, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CLEANED THE CC PROBES TO FIX THE SUPPRESSED CHEMISTRIES PER CUSTOMER TECHNICAL SPECIALIST'S RECOMMENDATION. AFTER CLEANING THE PROBES CUSTOMER STATED THAT THE CC SAMPLE PROBE COLLAR WASH IS DRIPPING WHICH CAUSED CC SIDE CHEMISTRIES TO BE SUPPRESSED. A BCI FIELD SERVICE ENGINEER (FSE) FOUND GEL IN THE WASH COLLAR VACUUM VALVE, CLEANED, AND THIS RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CARTRIDGE CHEMISTRY (CC) SAMPLE COLLAR WASH DRIP. NO INJURY OR EXPOSURE TO BIOHAZARDOUS MATERIALS WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1