BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2233735 · Received September 3, 2011

    Report

    Report Number
    2050012-2011-05041
    Event Type
    Malfunction
    Date Received
    September 3, 2011
    Date of Event
    June 19, 2011
    Report Date
    June 19, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K965240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. FSE WAS NOT ABLE TO IDENTIFY WHAT THE BLUE RESIDUE WAS BELOW THE ELECTROLYTE INJECTION CUP. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ELECTROLYTE INJECTION CUP VALVES AND PERFORMED PROBE ALIGNMENTS. THE FSE EXECUTED INSTRUMENT CHEMISTRY CALIBRATION AND QUALITY CONTROL ASSESSMENTS WITH ACCEPTABLE RESULTS. THE INSTRUMENT WAS RETURNED INTO SERVICE UPON COMPLETION OF THE VERIFIED REPAIRS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 A LEAK WAS OBSERVED ON A SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM. BLUE COLORED RESIDUAL APPEARED BELOW THE ELECTROLYTE INJECTION CUP. THE HEALTHCARE WORKERS INTERFACING WITH THE MACHINE WERE WEARING PERSONAL PROTECTIVE EQUIPMENT. NO INJURIES WERE REPORTED AND NO PERSONNEL SOUGHT ANY MEDICAL ATTENTION IN ASSOCIATION WITH THIS EVENT. NO PATIENT RESULTS WERE AFFECTED BY THIS EVENT. NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT WAS ASSOCIATED WITH THIS EVENT. THERE WAS A SPILL/EXPOSURE PLAN IN PLACE AT THE FACILITY AND THE MATERIAL SAFETY DATA SHEET WAS AVAILABLE AT THE FACILITY. INSTRUMENT ION-SELECTIVE ELECTRODE CHEMISTRY QUALITY CONTROL AND CALIBRATION RESULTS SHOWED NO EVIDENCE OF ERROR DURING THE TIMEFRAME OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 CLINICAL CHEMISTRY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1