BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON ® CHEMISTRY ANALYZER

    MDR report key: 1953428 · Received January 10, 2011

    Report

    Report Number
    2050012-2011-00039
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND THE CUSTOMER VERIFIED THAT THE SYRINGE WAS TIGHT. SERVICE REPLACED THE WASH SYRINGE VALVE AND PRIMED THE SYSTEM. THE ISSUE HAS BEEN RESOLVED. (B)(6).

    Additional Manufacturer Narrative · 1

    THE CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING AND THE CUSTOMER VERIFIED THAT THE SYRINGE WAS TIGHT. SERVICE REPLACED THE WASH SYRINGE VALVE AND PRIMED THE SYSTEM. THE ISSUE HAS BEEN RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CLOSE TUBE ACCESSION (CTA) LEAKING WASH BUFFER. NO INJURY AND/OR PERSONNEL EXPOSURE TO CHEMICAL OR BIO-HAZARDOUS MATERIAL WAS REPORTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CLOSE TUBE ACCESSION (CTA) LEAKING WASH BUFFER. NO INJURY AND/OR PERSONNEL EXPOSURE TO CHEMICAL OR BIO-HAZARDOUS MATERIAL 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