BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON LXI 725 SYSTEM

    MDR report key: 2182544 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02520
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 26, 2011
    Report Date
    June 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K023049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) FOUND THE WASH WHEEL TO BE DIRTY AND THE WASH ARM WAS LOOSE. THE FSE CLEANED THE WASH WHEEL AND REPLACED THE BEARINGS, PINCH ROLLERS AND THE PERIPUMP TUBING. THE FSE PERFORMED A ROUTINE SYSTEM CHECK AND INSTRUMENT ASSAY QUALITY CONTROL ASSESSMENT. BOTH ASSESSMENTS GENERATED ACCEPTABLE RESULTS. ALTHOUGH THE DEVICE WAS REPAIRED PRIOR TO RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A SYNCHRON LXI 725 SYSTEM FAILED SYSTEM CHECKS OVER A FOUR DAY PERIOD. THE CUSTOMER REPORTED AN UNKNOWN NUMBER OF PATIENT RESULTS OUT OF THE LABORATORY OVER THIS TIME PERIOD. HOWEVER THE CUSTOMER CONFIRMED THAT RESULTS WERE ONLY REPORTED OUTSIDE THE LABORATORY IN INSTANCES WHERE THE INSTRUMENT QUALITY CONTROLS RESULTS WERE WITHIN CUSTOMER ESTABLISHED SPECIFICATION. ALTHOUGH NO REPORTS OF DEATH OR SERIOUS INJURY HAVE BEEN REPORTED, THE IMPACT TO PATIENTS, IF ANY, IS UNKNOWN AT THIS TIME. NO PATIENT INFORMATION, INCLUDING INVOLVED PATIENT RESULTS, HAVE BEEN PROVIDED BY THE CUSTOMER. NO SAMPLE COLLECTION OR HANDLING INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON LXI 725 SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1