BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 1980876 · Received February 7, 2011

    Report

    Report Number
    2050012-2011-00392
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER FLUSHED THE REAGENT LINE WITH HOT DI WATER; HOWEVER THIS DID NOT RESOLVE THE ISSUE. A BCI FIELD SERVICE ENGINEER (FSE) FOUND THE ALBUMIN CUP DOES NOT DRAIN AND REPLACED THE VALVE FOR THE DRAIN. THE SYSTEM DID NOT DRAIN. FSE DISCOVERED THE DRAIN LINE WAS PLUGGED AND PRECEDED WITH CLEANING THE DRAIN LINE WITH BLEACH. THE SYSTEM STARTED TO DRAIN PROPERLY. FSE RECALIBRATED THE LAMP, CALIBRATED REAGENT, AND RAN QC.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT ALBUMIN CUP OVERFILLING AFTER PERFORMING THE CUP MAINTENANCE. 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