NA ELECTRODE

Additional Manufacturer Narrative

THE C303 ANALYZER SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER (FSE) CHECKED THE INSTRUMENT AND PERFORMED SUCCESSFUL ISE CHECKS, CALIBRATION, QC, AND PRECISION TESTING. CALIBRATION WAS LAST PERFORMED ON (B)(6) 2025 WITH ACCEPTABLE RESULTS. THE CUSTOMER RECALIBRATED ON (B)(6) 2025. QC WAS INITIALLY OUT OF RANGE ON THE DAY OF THE EVENT, HOWEVER, QC WAS WITHIN RANGE AFTER REPEATING. QC WAS ACCEPTABLE AFTER RECALIBRATION ON (B)(6) 2025. THE CUSTOMER FOUND THEIR QC RANGES WERE WIDER THAN COMPARED TO THE PEER DATA. IF THEIR RANGES WERE ADJUSTED TO MATCH THE PEER DATA THEIR REPEAT MEASUREMENT ON THE DATE OF THE EVENT WOULD HAVE BEEN OUT OF RANGE, PROMPTING THEM TO TROUBLESHOOT THE ISSUE FURTHER. PRODUCT LABELING STATES: "THE CONTROL INTERVALS AND LIMITS SHOULD BE ADAPTED TO EACH LABORATORY¿S INDIVIDUAL REQUIREMENTS. VALUES OBTAINED SHOULD FALL WITHIN THE DEFINED LIMITS. EACH LABORATORY SHOULD ESTABLISH CORRECTIVE MEASURES TO BE TAKEN IF VALUES FALL OUTSIDE THE DEFINED LIMITS." IT IS THE CUSTOMER¿S RESPONSIBILITY TO DETERMINE THE APPROPRIATE QC RANGES FOR EVALUATING THEIR PERFORMANCE BEFORE RUNNING PATIENT SPECIMENS. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE ISSUE WAS RESOLVED DUE TO THE CUSTOMER¿S ACTIONS OF RECALIBRATING, RUNNING QC, AND REPEATING PATIENT SAMPLES.

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED LOW RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR NA ELECTRODE (NA) ON A COBAS C 303 ANALYTICAL UNIT. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS FOR 3 PATIENT SAMPLES. PATIENT 1 INITIAL RESULT WAS 134.6 MMOL/L. ON (B)(6) 2025 THE REPEAT RESULT FROM THE SAME ANALYZER WAS 141.2 MMOL/L. THE REPEAT FROM A DIFFERENT C303 ANALYZER WAS 142.6 MMOL/L. PATIENT 2 INITIAL RESULT WAS 124 MMOL/L. THE REPEAT RESULT WAS 118.5 MMOL/L. THE REPEAT RESULT FROM THE DIFFERENT C303 ANALYZER WAS 124.5 MMOL/L. PATIENT 3 INITIAL RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 133 MMOL/L. THE REPEAT RESULT FROM THE DIFFERENT C303 ANALYZER WAS 138.6 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THEY WERE QUESTIONED BY THE PHYSICIAN. THE REPEAT RESULTS FROM THE DIFFERENT C303 ANALYZER WERE BELIEVED TO BE CORRECT.