BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON CX5CLINICAL SYSTEM

    MDR report key: 2211537 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04011
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 7, 2008
    Report Date
    July 17, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE CALL OR EXAMINATION OF THE SYSTEM WAS CONDUCTED. THE CUSTOMER PERFORMED MAINTENANCE, CLEANED THE FLOW CELL AND RECALIBRATED THE SYSTEM. THE CUSTOMER THEN RESUMED NORMAL OPERATION. NO FURTHER REPORTS WERE RECEIVED. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUSLY LOW SODIUM RESULTS WERE GENERATED BY THE SYNCHRON CX5 CLINICAL SYSTEM. THE ATTENDING PHYSICIAN NOTIFIED THE FACILITY TWO DAYS AFTER THE RESULTS WERE INITIALLY REPORTED AND QUESTIONED THE VALIDITY OF THE RESULTS. THE CUSTOMER PERFORMED MAINTENANCE ON THE SYSTEM, CLEANED THE FLOW CELL AND CALIBRATED THE SYSTEM. THE FACILITY RETESTED FIFTY (50) SAMPLES AND OBTAINED RESULTS WITHIN EXPECTATION. THE RESULTS OF THE RETESTED SAMPLES WERE NOT RELEASED TO THE PHYSICIAN BECAUSE THE SAMPLES WERE NOT PROPERLY STORED. THERE WERE NO CHANGES TO THE PATIENT'S CARE OR TREATMENT RELATED TO THIS EVENT. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS OR NEED FOR MEDICAL INTERVENTION TO PREVENT OR PRECLUDE SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON CX5CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ISE ELECTROLYTE BUFFER:| ISE ELECTROLYTE REFERENCE: