BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX9 ALX CLINICAL SYSTEM

    MDR report key: 2091502 · Received May 17, 2011

    Report

    Report Number
    2050012-2011-01574
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 19, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K950958
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC PRIOR TO THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES BUT ON THE UPPER END OF THE RANGE. QC AFTER THE EVENT WAS WITHIN THE LAB'S ESTABLISHED RANGES AFTER THE SYSTEM WAS RECALIBRATED. THE CUSTOMER REMOVED BUBBLES FROM THE RATIO PUMP AND BLEACHED THE FLOWCELL AFTER THE EVENT OCCURRED. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THAT THE TOP HALF OF THE FLOWCELL WAS CLOUDY AS WELL AS ISE REFERENCE REAGENT LINE. FSE FOUND BUILDUP IN NA PORT OF FLOWCELL AND PERFORMED A PREVENTIVE MAINTENANCE (PM), CLEANING AND REPLACED PARTS (K ELECTRODE AND CARBON BRIDGE) AND VERIFIED PERFORMANCE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FALSE SODIUM (NA) AND POTASSIUM (K) AND FALSE LOW CHLORIDE (CL) RESULTS GENERATED BY THE SYNCHRON CX9 ALX CLINICAL SYSTEM ON ONE PATIENT SAMPLE. THE SAMPLE ORIGINALLY HAD NORMAL ISE RESULTS BUT DUE TO A LOW ANION GAP, THE SAMPLE WAS RERUN AND THE RERUN GAVE THE FALSE RESULTS. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX9 ALX CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1