BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2211561 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-04118
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 19, 2008
    Report Date
    June 20, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Removal / Correction Number
    Z-0863-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE CALL WAS INITIATED BY THE MANUFACTURER. THE CUSTOMER RECALIBRATED THE SYSTEM AND RAN QUALITY CONTROLS WHICH CORRECTED THE REPORTED PROBLEM. THE CUSTOMER THEREFORE CANCELED THE REQUESTED SERVICE CALL. NO EXAMINATION OF THE SYSTEM WAS CONDUCTED. WITHOUT AN EXAMINATION OF THE SYSTEM A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS IS ONE OF THREE MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER PROVIDED DATA FOR THREE PATIENT EVENTS. REFERENCE THE MDR NUMBERS BELOW FOR ALL ASSOCIATED EVENTS. MDR# 2050012-2011-04117, 04119. 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 ELECTROLYTE RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY AND THE VALIDITY WAS QUESTIONED BY THE FLOOR NURSES. THE OPERATOR THEN RAN QUALITY CONTROLS AND NOTED THAT THE QUALITY CONTROLS WERE NOT IN SPECIFICATION. THE SYSTEM WAS RECALIBRATED. THE SAMPLES WERE THEN RETESTED ON ANOTHER SYSTEM AND CORRECTED RESULTS WERE ISSUED OUT OF THE LABORATORY. IT IS NOT KNOWN IF THERE WAS ANY CHANGE TO THE PATIENTS' CARE OR TREATMENT. THERE ARE 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 UNICEL DXC 800 SYNCHRON SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

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