BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2072299 · Received April 28, 2011

    Report

    Report Number
    2050012-2011-01257
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 31, 2011
    Report Date
    March 31, 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 THE 10PSI LINE CONNECTED TO FITTING ON NO FOAM CAP WAS LOOSE AND SECURED TUBING ON FITTING. FSE DID NOT SEE FURTHER EVIDENCE OF LEAKING THROUGH THE DAY SHIFT. NO LOOSE OR CRACKED FITTINGS WERE FOUND IN THE HYDRO DRAWER.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A PUDDLE HAD FORMED UNDER THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE PUDDLE EVAPORATED RAPIDLY AND LEFT NO RESIDUE. CUSTOMER STATED THE TUBING AND FITTING FOR THE NO FOAM CAP WAS LOOSE. NO INJURY WAS REPORTED.

    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