BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 2080915 · Received May 7, 2011

    Report

    Report Number
    2050012-2011-01438
    Event Type
    Malfunction
    Date Received
    May 7, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND STORAGE INFORMATION WERE NOT PROVIDED. PRIOR TO THE EVENT, QC WAS WITHIN LAB ESTABLISHED RANGES. AFTER THE EVENT, QC WAS NOT RUN PRIOR TO RECALIBRATION. QC AFTER RECALIBRATION WAS WITHIN RANGE. BCI FIELD SERVICE ENGINEER (FSE) CLEANED THE CL PORT, CHANGED THE CO2 ELECTRODE MEMBRANE AND REPLACED THE CARBON BRIDGE. FSE ALSO IDENTIFIED A LEAK AROUND THE BOTTOM CYLINDER OF THE RATIO PUMP AND REPLACED THE RATIO PUMP. INSTRUMENT PERFORMANCE WAS VERIFIED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE SYNCHRON LX20 ANALYZER GENERATED FALSE HIGH CO2 RESULT OF 33.7 MMOL/L FOR ONE (1) PATIENT. WHEN THE ANION GAP VALUE ALERTED THE CUSTOMER TO THE HIGH CO2, THE SAMPLE WAS RETESTED ON AN ALTERNATE INSTRUMENT, AND THE RESULT OF 25.3 MMOL/L WAS REPORTED. THE FALSE HIGH RESULT WAS NOT REPORTED OUT OF THE LAB AND THERE IS NO AFFECT TO PATIENT.

    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