BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

    MDR report key: 2202491 · Received August 5, 2011

    Report

    Report Number
    2050012-2011-03931
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    May 15, 2008
    Report Date
    May 16, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PERFORMED TROUBLESHOOTING OF THE SYS WHILE ON THE TELEPHONE WITH BCI PERSONNEL. THE CUSTOMER WAS INSTRUCTED TO CLEAN THE ELECTROLYTE INJECTOR CUP AND FLUSH THE ISE FLOWCELL WITH CLEANING SOLUTION. THE CUSTOMER AGREED TO MONITOR AND CALL BCI BACK IF THERE WERE ANY MORE OCCURRENCES. AS OF (B)(4) 2008, THERE CUSTOMER HAD NOT CALLED BACK WITH FURTHER PROBLEMS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 1 OF 3 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 2050012-2011-03932, MDR 2050012-2011-03933.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC (BCI) TO REPORT THAT THREE OF THEIR UNICEL DXC 800 SYNCHRON CLINICAL SYS WERE EXPERIENCING LOW ANION GAPS AFTER THE LATEST SOFTWARE UPGRADES AND AFTER PERFORMING WEEKLY FLOW CELL MAINTENANCE. THE CUSTOMER REPORTED THAT CHLORIDE (CL) RESULTS HAVE BEEN FOUND TO BE ERRONEOUSLY HIGH. THIS EVENT AFFECTED AN UNK NUMBER OF PT SAMPLES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LAB. THERE ARE NO REPORTS OF DEATH OR SERIOUS INJURY RELATED TO THIS EVENT. UPON REPEAT TESTING, THE ANION GAPS WERE FOUND TO BE HIGHER AND THE CL RESULTS WERE LOWER. THE SODIUM (NA) AND CARBON DIOXIDE (CO2) RESULTS ARE ALSO USED TO CALCULATE THE ANION GAP WERE NOT SIGNIFICANTLY CHANGED. A QUALITY CONTROL (QC) RUN PRIOR TO THE EVENT GAVE RESULTS WITHIN THE LAB'S ESTABLISHED RANGES. THE PROBLEM OCCURRED AFTER THE AUTOMATED WEEKLY FLOW CELL MAINTENANCE PROCEDURE WAS PERFORMED. HOWEVER, FROM THE INFO PROVIDED, A CLEAR ROOT CAUSE CANNOT BE IDENTIFIED. THIS IS REPORT 1 OF 3 FOR SYS 1 OF 3.

    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