BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON SYSTEM

    MDR report key: 2211559 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-03939
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 21, 2008
    Report Date
    June 21, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERVICE CALL OR EXAMINATION OF THE SYSTEM WAS CONDUCTED. THE CUSTOMER RECALIBRATED THE SYSTEM AND RESUMED NORMAL OPERATION WITH QUALITY CONTROLS RUN EVERY TWO HOURS. THERE WERE NO FURTHER REPORTS OF ERRONEOUS RESULTS. WITHOUT AN EXAMINATION OF THE SYSTEM OR DATA TO REVIEW - NO ROOT CAUSE CAN BE DETERMINED; 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 TWENTY (20) INDIVIDUAL MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED 20 SEPARATE PATIENT EVENTS. REFERENCE THE BELOW MDR NUMBERS FOR ALL ASSOCIATED EVENTS. MDR # 2050012-2008-00027, 2050012-2011-03934, 03935, 03936, 03937, 03938, 03940, 03941, 03942, 03943, 03944, 03945, 03946, 03947, 03948, 03949, 03950, 03951, 03952.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ERRONEOUS SODIUM AND CHLORIDE RESULTS WERE GENERATED BY THE UNICEL DXC 800 SYNCHRON SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. SYSTEM CALIBRATION AND QUALITY CONTROLS WERE WITHIN SPECIFICATION PRIOR TO THE EVENT. ALL SAMPLES FROM THE LAST CALIBRATION WERE RETESTED ON THE FACILITY'S SECOND SYSTEM AND YIELDED RESULTS WITHIN EXPECTATIONS. TWENTY (20) AMENDED RESULTS WERE ISSUED. ONE PATIENT HAD UNSPECIFIED TREATMENT BASED ON THE ERRONEOUS RESULTS. IT IS NOT KNOWN IF THERE WERE ANY CHANGES TO THE REMAINING 19 PATIENTS' CARE OR TREATMENT.

    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: