BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 1984374 · Received February 10, 2011

    Report

    Report Number
    2050012-2011-00416
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 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
    MO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER STATED THAT THE SYRINGES AND THE THREE (3) WAY VALVES WERE PREVIOUSLY REPLACED BY THEIR SERVICE FOR THE SAME PROBLEM. A BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE REPLACED THE REAGENT PROBES T-VALVE, 7 CUVETTES, AND ADJUSTED THE BELTS FOR THE REAGENTS AND CRANES. THE FSE ALSO PERFORMED ALL ASSOCIATED ALIGNMENTS AND RAN CONTROLS. SERVICE WILL CONTINUE TO MONITOR THE INSTRUMENT FOR FURTHER ISSUES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE REAGENT PROBES CONTINUED LEAKING INTO THE REAGENT CAROUSEL OF THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. 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