BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® LX20 PRO CHEMISTRY ANALYZER

    MDR report key: 1883638 · Received October 26, 2010

    Report

    Report Number
    2050012-2010-01058
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 2, 2010
    Report Date
    October 26, 2010
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE FOUND THE FITTING ON THE MODULAR CHEMISTRY (MC) LEVEL SENSE BEAD WAS LOOSE. FSE CLEANED THE FLOW CELL AND ALL THE ELECTRODES. REPLACED THE CO2 REFERENCE ELECTRODE AND CO2 MEASURING ELECTRODE MEMBRANE. THE FLAPPER ON THE ELECTRICAL CONNECTION (EIC) VALVE WAS FOUND TO BE CRACKED SO THE FSE REPLACED IT. THE FSE ALIGNED THE MC PROBE AND ALL ISE REAGENTS WERE REPLACED. AS OF (B)(4) 2010, THERE WERE NO FURTHER CALLS TO THE BCI HOTLINE FOR ISE PROBLEMS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) IN REGARDS TO OBTAINING FALSE HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS THAT WERE GENERATED BY THE SYNCHRON LX20 PRO CHEMISTRY ANALYZER FOR 2 PATIENT SAMPLES. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT, WHICH PRODUCED LOWER RESULTS AND WERE REPORTED OUT OF THE LAB. THERE WAS NO AFFECT TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1