BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2070066 · Received April 26, 2011

    Report

    Report Number
    2050012-2011-01309
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    March 27, 2011
    Report Date
    March 27, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL SUPPORT DIRECTED THE CUSTOMER TO CLEAN THE DI LID. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND CLEANED THE DI WATER CAP AND ALSO CHECKED FOR BENDS IN THE LINE; ALL LINES WERE OPERATING PROPERLY. THE FSE PERFORMED A FLOW CHECK AND DETERMINED THAT THE FLOW RATE FROM THE EXTERNAL WATER SOURCE TO THE INSTRUMENT WAS TOO SLOW. THE FSE DID NOT IDENTIFY SOURCE OF YELLOW CRYSTAL BUILDUP OR DETERMINE THE IDENTITY OF THE CRYSTALS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WAS GENERATING DI WATER RESERVOIR NOT FILLING ERRORS AND WHILE TROUBLESHOOTING DISCOVERED A YELLOW CRYSTAL BUILDUP ON THE LID OF THE DI WATER RESERVOIR. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. DXC 800 PRO NA

    Patients

    Seq Age Sex Outcome Treatment
    1