BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2162770 · Received July 14, 2011

    Report

    Report Number
    2050012-2011-02964
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND FOUND BROKEN CAP PIERCER "COMPONENT". FSE ORDERED THE REQUIRED PARTS AND DISABLED THE CAP PIERCER. THE CUSTOMER WAS ABLE TO USE THE INSTRUMENT WITHOUT THE CAP PIERCER FEATURE. FSE RETURNED ON-SITE (B)(4) 2011 AND REPLACED THE CAP PIERCER SHUTTLE, O-RING AND HOUSING. THE CAP PIERCER OPERATION WAS CONFIRMED. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT THEY HAD NOTICED THE BLUE RACKS (NON-RESERVED AND USED FOR CAP PIERCING) IN THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER WERE WET. THE CALIBRATION AND QC RACKS (RESERVED AND NOT USED FOR CAP PIERCING) WERE NOT WET. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.

    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