BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2411089 · Received January 11, 2012

    Report

    Report Number
    2050012-2012-00003
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 13, 2011
    Report Date
    December 13, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A LEAK AT REAGENT PROBE B OF THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM WHERE THE WATER LINE ATTACHES TO THE WASH COLLAR. CUSTOMER REPORTED THAT < 1ML OF WATER WAS SPILLED. BEC CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER IF ENOUGH TUBING IS PRESENT, THEY CAN TRIM IT AND REINSTALL THE TUBE. CUSTOMER REPORTED THAT THEY TRIMMED AND REPAIRED THE TUBING. CUSTOMER REPORTED THAT ERRONEOUS RESULTS WERE NOT GENERATED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. TO DATE, CUSTOMER HAS NOT REPORTED ON ANY FURTHER LEAK AT REAGENT PROBE B OF THE SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1