BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2260093 · Received August 26, 2011

    Report

    Report Number
    2050012-2011-04597
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    October 8, 2008
    Report Date
    October 9, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO EXAMINATION OR EVALUATION OF THE SYSTEM WAS CONDUCTED. THE MANUFACTURERS' CUSTOMER REPRESENTATIVE DISCUSSED SYSTEM CLEANING PROCEDURES WITH THE CUSTOMER. WITHOUT AN EVALUATION OF THE SYSTEM A SPECIFIC ROOT CAUSE OF THE EVENT CANNOT BE IDENTIFIED; ACCORDINGLY, NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADDITIONAL REPORTABLE EVENTS. THIS IS ONE OF 37 MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED 37 PATIENT RESULTS WERE INVOLVED. REFERENCE THE MDR NUMBERS BELOW FOR ALL ASSOCIATED EVENTS. 2050012-2011-04577, 04579, 04580, 04581, 04582, 04583, 04584, 04585, 04586, 04587, 04588, 04589, 04590, 04591, 04592, 04593, 04594, 04595, 04598, 04599, 04600, 0401, 04602, 0403, 04604, 04605, 04606, 04607, 04608, 04609, 04610, 04611, 04612, 04613, 04614.

    Description of Event or Problem · 1

    CUSTOMER REPORTED 37 ERRONEOUS SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE OPERATOR RECALIBRATED THE SYSTEM AND RAN QUALITY CONTROLS. THE SAMPLES WERE THEN RETESTED AND THE RESULTS OBTAINED WERE WITHIN EXPECTATION. AMENDED RESULTS WERE ISSUED FROM THE LABORATORY. IT IS NOT KNOWN IF THERE WERE ANY CHANGES TO THE PATIENTS' CARE OR TREATMENT RELATED TO THIS EVENT. 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 BUFFER| ISE ELECTROLYTE REFERENCE