BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2121859 · Received May 20, 2011

    Report

    Report Number
    2050012-2011-01612
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 13, 2009
    Report Date
    April 13, 2009
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RECALIBRATION OF THE SYSTEM ALLEVIATED THE PROBLEM. AN FSE (FIELD SERVICE ENGINEER) TOOK THE FLOW CELL APART, REPLACED THE CARBON BRIDGE, CLEANED ALL PORTS AND PRIMED THE SYSTEM BUT A CLEAR ROOT CAUSE COULD NOT BE DETERMINED. THIS REPORTED EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 TO (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT ERRONEOUSLY LOW SODIUM (NA), CHLORINE (CL) AND POTASSIUM (K) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 800 INSTRUMENT. THE CUSTOMER NOTICED THAT ROUTINE QC (QUALITY CONTROL) RESULTS WERE OUT OF RANGE LOW, SO THE ISE (ION-SELECTIVE ELECTRODE) SYSTEM WAS RECALIBRATED, QC WAS RUN AGAIN AND WAS FOUND TO BE WITHIN THE LAB'S ESTABLISHED RANGES. CUSTOMER THEN RE-RAN RANDOM PATIENT SAMPLES AND DISCOVERED THAT THE NA, CL, AND K RESULTS WERE HIGHER THAN THE REPORTED RESULTS. SEVERAL PATIENT RESULTS WERE AMENDED. ERRONEOUS AND CORRECTED RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNKNOWN WHETHER THERE WAS ANY MODIFICATION TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK