ARCHITECT C8000 SYSTEM

Description of Event or Problem

THE CUSTOMER OBSERVED A FALSELY ELEVATED SODIUM RESULT FOR ONE PATIENT ON THE ARCHITECT C8000 ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL 174 MMOL/L, REPEAT 144 MMOL/L. THE CUSTOMER MENTIONED THAT THE TECHNICIAN (BEFORE HE REPORTED OUT A CRITICALLY HIGH NA RESULT=174 MMOL/L, WITH THE CONTROLS OUT OF RANGE ON THIS ANALYZER) DID NOT REPEAT THE SAMPLE PER LAB PROTOCOL. THE TECHNICIAN REALIZED IT RIGHT AWAY AND CALLED THE ER WHERE THE PATIENT WAS, REPEATED THE SAME SAMPLE ON THEIR OTHER ARCHITECT C8000 BACKUP ANALYZER WITH ICT CONTROLS IN RANGE AND GOT A 144 MMOL/L. TECHNICIAN CALLED THE CORRECT RESULT TO ER AND PATIENT WAS NOT TREATED ACCORDING TO THE INCORRECT RESULT REPORTED EARLIER. ABBOTT INSTRUMENT SERVICE HELPED THE CUSTOMER REPLACE THE ICT MODULE TWICE WITH NO RESOLUTION. ABBOTT INSTRUMENT SERVICE VERIFIED THE O-RINGS ARE SEATED PROPERLY, VERIFIED THE ICT SYRINGE IS WORKING PROPERLY AND THE ICT SOLUTION IS ABOUT 3/4 FULL. NO FURTHER DETAILS ABOUT THE PATIENT WERE PROVIDED.

Additional Manufacturer Narrative

FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF HISTORICAL DATA, A REVIEW OF LABELING AND SERVICE OF THE ARCHITECT INSTRUMENT AND ICT MODULE. NO ADVERSE TREND WAS IDENTIFIED AFTER REVIEWING HISTORICAL DATA AND COMPLAINTS. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE: REVIEW OF THE ARCHITECT C8000 SERVICE MANUAL FOR ICT TUBING (LN 7-93269-01) STATES THAT ONCE IT HAS BEEN REPLACED, VERIFICATION SHOULD BE PERFORMED PER OPERATION AND SERVICE PROCEDURES. IT IS IMPERATIVE TO ENSURE APPROPRIATE QUALITY CONTROL IS WITHIN SPECIFICATION AND CALIBRATE AS NECESSARY. A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED AND CONCLUDED THAT THE DISCREPANT RESULTS WERE DUE TO BUILD-UP OF DEBRIS IN THE ICT TUBING (LIST NUMBER 7-93269-01). A DEFICIENCY OF THE ICT TUBING (LIST NUMBER 7-93269-01) WAS NOT IDENTIFIED NOR IS THERE SUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION OCCURRED. THE ISSUE WAS CONSIDERED RESOLVED BY REPLACING THE ICT TUBING.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).