ARCHITECT CEA

Additional Manufacturer Narrative

THE DEVICE EVALUATION WAS REASSESSED AND CONCLUDED THAT A MALFUNCTION OCCURRED, THEREFORE THE DEVICE WAS NOT PERFORMING AS INTENDED.

Additional Manufacturer Narrative

UDI: (B)(4). LOT/SERIAL NUMBER WAS MANUFACTURED PRIOR TO UDI COMPLIANCE DATE; THEREFORE, ONLY A DI IS PROVIDED. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED FALSELY DECREASED CEA RESULTS ON ONE PATIENT. THE RESULTS PROVIDED WERE: INITIAL = 5.0 / REPEAT = 15,000. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

Additional Manufacturer Narrative

THE CUSTOMER OBSERVED A DEPRESSED CEA RESULT OF <0.5NG/ML WHEN USING ARCHITECT CEA, LIST NUMBER 7K68-27, LOT NUMBER 61610LF00 ON THEIR ARCHITECT I2000SR ANALYSER. THE COMPLAINT TEXT STATES THAT THE CUSTOMER AGREES THAT IT WAS A TEMPORARY INCIDENT AND THAT POOR SAMPLING FROM AIR BUBBLES COULD HAVE CAUSED THE DEPRESSED RESULT. A REVIEW OF COMPLAINTS DETERMINED THERE ARE NO TRENDS FOR ARCHITECT CEA. NO PATIENT SAMPLE WAS AVAILABLE TO ASSIST IN THE INVESTIGATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION FOR LOT 61610LF00. A REVIEW OF LABELING SHOWS ADEQUATE INFORMATION IS PROVIDED TO ADDRESS DISCREPANT RESULTS INCLUDING SAMPLE INTEGRITY / SAMPLE HANDLING ISSUES. THIS INCLUDES INSPECTION OF ALL SAMPLES FOR BUBBLES AND THE REMOVAL OF BUBBLES WITH AN APPLICATOR STICK PRIOR TO ANALYSIS. THE ARCHITECT SYSTEM OPERATIONS MANUAL PROVIDES TROUBLESHOOTING FOR FALSELY ELEVATED RESULTS. BASED ON ALL AVAILABLE INFORMATION AND THIS INVESTIGATION, THE ASSAY PERFORMED AS INTENDED AND NO PRODUCT DEFICIENCY WAS IDENTIFIED.