BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 ANALYZER (WITHOUT CAP PIERCER)

    MDR report key: 1935629 · Received December 22, 2010

    Report

    Report Number
    2050012-2010-01716
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND A DEFECTIVE FLOAT SWITCH ON THE WASH SOLUTION CANISTER WHICH CAUSED THE CANISTER TO OVERFLOW AND CAUSED THE SOLUTION TO GET IN THE REGULATORS AND LINES. FSE REPLACED THE FLOAT SWITCH AND THE SYSTEM WAS RESUMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING FLUID LEAK FROM HYDRO LINE. THE REAGENT CONNECTED TO THIS LINE WAS WASH SOLUTION. NO INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 ANALYZER (WITHOUT CAP PIERCER) CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1