UNICEL DXC 800 SYNCHRON CLINICAL SYSTEM

Additional Manufacturer Narrative

A BCI FSE (FIELD SVC ENGINEER) WAS DISPATCHED TO THE SITE ON (B)(4) 2009 AND PERFORMED TROUBLESHOOTING. THE FSE FOUND THAT THE INSTRUMENT WAS FUNCTIONING PROPERLY BUT STILL LEFT NA ELECTRODES WITH THE CUSTOMER. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE CUSTOMER PROCEEDED FROM THIS POINT FORWARD TO RECALIBRATE AND RUN CONTROLS MORE FREQUENTLY. THIS IS 1 OF 25 INDIVIDUAL MEDWATCH REPORTS WHICH ARE RELATED TO THIS EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN 1/1/2008 AND 10/23/2010 FOR ADD'L REPORTABLE EVENTS. THIS IS ONE OF TWENTY-FIVE (25) SEPARATE MEDWATCH REPORTS BEING SUBMITTED AS THIS EVENT INVOLVES 25 SEPARATE PT EVENTS THAT WERE REPORTED OUT OF THE LAB.

Description of Event or Problem

THE CUSTOMER REPORTED TO BECKMAN COULTER, INC (BCI) THAT ERRONEOUSLY LOW SODIUM (NA) RESULTS WERE OBTAINED ON THEIR UNICEL DXC 800 INSTRUMENT, THE RESULTS WERE REPORTED OUT OF THE LAB AND THAT THERE HAVE BEEN SIMILAR ISSUES WITH OTHER DXC 800 INSTRUMENTS. PRIOR TO THE EVENT, THE ISE (ION-SELECTIVE ELECTRODE) SYS WAS CALIBRATED AND THE QC (QUALITY CONTROL) RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGE. AROUND 3 AM ON (B)(6) 2009, ABOUT 25 NA RESULTS WERE RUNNING LOW AND THE ERRONEOUS RESULTS WERE DISCOVERED LATER. THE ISE SYS WAS RE-CALIBRATED AND QC RECOVERED WITHIN RANGE. SAMPLES WERE REPEATED AND AMENDED REPORTS WERE ISSUED. THE CUSTOMER DID NOT PROVIDE ANY INFO REGARDING PT OR SAMPLE DATA. WHILE THERE IS NO REPORT OF ANY ADVERSE EVENT OR SERIOUS INJURY RELATED TO THIS EVENT, IT IS UNK WHETHER THERE WAS ANY CHANGE TO PT TREATMENT.