BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO ANALYZER (W/O CAP PIERCER)

    MDR report key: 2013475 · Received March 10, 2011

    Report

    Report Number
    2050012-2011-00621
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 12, 2011
    Report Date
    February 12, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JGS
    PMA / PMN Number
    K011213
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THAT THE RATIO PUMP WAS WORN AND REPLACED THE PISTON. FSE ALSO REPLACED BOTH NA ELECTRODES.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE HIGH SODIUM (NA) RESULTS. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLES WERE RERUN ON AN ALTERNATE INSTRUMENT AND THOSE RESULTS WERE REPORTED. THERE WAS NO AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® LX20 PRO ANALYZER (W/O CAP PIERCER) CLINICAL CHEMISTRY ANALYZER JGS BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1