BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 2110841 · Received June 2, 2011

    Report

    Report Number
    2050012-2011-02087
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011 A BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE NOISY CARTRIDGE CHEMISTRY REAGENT SYRINGE DRIVE AND 4-WAY HAMILTON A/B VALVE. AS OF (B)(4) 2011, NO FURTHER ISSUES WERE NOTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT CUVETTE FAILED WATER BLANK AND BOTH REAGENT PROBES LEAKED. THE CUSTOMER WAS WEARING PPE. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. LX-20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1