BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1971279 · Received January 26, 2011

    Report

    Report Number
    2050012-2011-00263
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CLEANED UP THE FLUID, BUT WAS UNABLE TO LOCATE THE CAUSE OF THE LEAK. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2010 AND FOUND THAT THE SAMPLE PROBE HAD GEL IN THE TUBING. THE FSE THEN VERIFIED THAT THE MODULE CHEMISTRY (MC) AND THE CARTRIDGE CHEMISTRY (CC) PROBES WERE CLEAR AND VERIFIED LEVEL SENSE ON THE SYSTEM.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT FLUID WAS LEAKING FROM THE REAGENT PROBE ONTO THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER COVERS. THERE WAS NO AFFECT ON PATIENT RESULTS OR OPERATOR EXPOSURE PERTAINING TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1