UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM

Description of Event or Problem

CUSTOMER REPORTED THAT FIFTY (50) ERRONEOUSLY SODIUM AND CALCIUM RESULTS WERE GENERATED BY THE UNICEL DXC 600I SYNCHRON ACCESS SYSTEM. THE RESULTS WERE REPORTED OUT OF THE LABORATORY. ONE PATIENT WAS ADMITTED TO THE HOSPITAL BASED UPON AN ERRONEOUSLY LOW CALCIUM RESULT. SYSTEM CALIBRATION AND QUALITY CONTROLS WERE WITHIN SPECIFICATION PRIOR TO THE EVENT. THE SAMPLES WERE RETESTED AND YIELDED RESULTS WITHIN EXPECTATION. AMENDED RESULTS WERE ISSUED. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE FOLLOWING DAY. IT IS NOT KNOWN IF THERE WERE ANY CHANGES TO THE PATIENTS' CARE OR TREATMENT. THERE ARE NO REPORTS OF ANY TREATMENT CAUSING HARM TO THIS PATIENT.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) VISITED THE FACILITY AND EXAMINED THE SYSTEM. CULTURES OF THE SYSTEM WERE NOT TAKEN OR PROVIDED. THE FSE FOUND AN UNSPECIFIED WHITE PRECIPITATE IN THE FLOW CELL. THE FSE CLEANED THE FLOW CELL AND REPLACED THE CARBON BRIDGE. ALTHOUGH SEVERAL PARTS WERE REPLACED AND THIS MEASURE MAY HAVE RESOLVED THE PROBLEM, A CLEAR ROOT CAUSE COULD NOT BE DETERMINED; ACCORDINGLY NO CONCLUSION CAN BE DRAWN. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.