BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER.

    MDR report key: 2080712 · Received May 6, 2011

    Report

    Report Number
    2050012-2011-01398
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE INFORMATION WAS NOT PROVIDED. THE SYSTEM WAS CALIBRATED AT 0215 AND AGAIN AT 0230. PATIENT SAMPLES WERE RUN AND REPORTED. THE SYSTEM WAS RECALIBRATED AT 0808, AND QC RUN AT 0828. THE LAB CONFIRMED THAT THE OPERATOR DID NOT RUN QC AFTER LOADING REAGENT AND RECALIBRATING. THE SAMPLES WERE RERUN AFTER THE SYSTEM WAS RECALIBRATED AT 0808, AND RECOVERY WAS HIGHER, MATCHING THE OTHER INSTRUMENT. A BCI FIELD SERVICE ENGINEER (FSE) REPLACED: WORN O-RINGS. BROKEN NA ELECTRODE CONNECTOR. MODULAR CHEMISTRY SAMPLE PROBE. FSE VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS LOW SODIUM (NS), POTASSIUM (K), AND CHLORIDE (CL) RESULTS GENERATED BY THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE LABORATORY REPEATED THE SAMPLES ON AN ALTERNATE UNIT ONCE THEY NOTICED A TREND OF LOW RESULTS. HIGHER RESULTS WERE OBTAINED AND THE AMENDED REPORTS WERE INITIATED. TREATMENT WAS NOT INITIATED OR WITHHELD BASED UPON THE FALSE RESULTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER. CLINICAL CHEMISTRY ANALYZER, JJE BECKMAN COULTER INC. DXC600 PRO N/A

    Patients

    Seq Age Sex Outcome Treatment
    1