BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER

    MDR report key: 1897130 · Received November 11, 2010

    Report

    Report Number
    2050012-2010-01265
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 23, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC IS RUN EVERY 4 HOURS AND SHOWED INTERMITTENT HIGH FLYERS PRIOR TO THE EVENT. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND REPLACED THE RATIO PUMP PISTON WHICH RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING INTERMITTENTLY HIGH NA, K, CL AND CO2 RESULTS GENERATED BY THE SYNCHRON LX20 PRO ANALYZER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1