BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX 20 PRO CLINICAL SYSTEMS

    MDR report key: 2060315 · Received April 15, 2011

    Report

    Report Number
    2050012-2011-01150
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K011213
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE CUSTOMER PERFORMED CONTROLS BEFORE OR AFTER THIS INCIDENT. BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE PERFORMED MAJOR PREVENTIVE MAINTENANCE (PM), REPLACED ALL ELECTRODES, CLEANED THE FLOWCELL, CHANGED THE CARBON BRIDGE AND REBUILD RATIO PUMP. FSE CALIBRATED ALL CHEMISTRIES, RAN QC AND FOUND NO ERROR. AS OF (B)(4) 2011, THE CUSTOMER HAS NOT CONTACTED BCI IN REGARDS TO THIS ISSUE SINCE COMPLETION OF THE SERVICE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE SYNCHRON LX20 ANALYZER GENERATED ERRONEOUS ELECTROLYTE (NA, CL AND CO2) RESULTS. THE CUSTOMER REVIEWED DELTA CHECKS AND REPEATED THE TEST ON ANOTHER INSTRUMENT. RESULTS WERE REPORTED OUT OF THE LAB AND THE CORRECTED RESULTS WERE AMENDED WITHIN 5 MINUTES. THEREFORE, PATIENT TREATMENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX 20 PRO CLINICAL SYSTEMS CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. LX 20 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1