BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LX20 PRO SYSTEM

    MDR report key: 2441706 · Received February 7, 2012

    Report

    Report Number
    2050012-2012-00397
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 23, 2012
    Report Date
    January 23, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2012, CUSTOMER REPORTED THAT THE ION SELECTIVE ELECTRODE (ISE) WAS FAILING CALIBRATION AND THE ELECTROLYTE INJECTION CUP (EIC) WAS OVERFLOWING ON THE LX20 PRO INSTRUMENT. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THAT THE ELECTRICAL CONNECTOR FOR THE EIC VALVES WERE NOT FULLY SEATED. FSE RESEATED THE CONNECTOR, CLEANED THE EIC AND THE MOUNT FOR THE EIC. THIS RESOLVED THE ISSUE AND NO FURTHER LEAKS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LX20 PRO SYSTEM ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER, INC. LX20 PRO

    Patients

    Seq Age Sex Outcome Treatment
    1