NA ELECTRODE

Additional Manufacturer Narrative

SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE COBAS PRO ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION WAS LAST PERFORMED ON 18-JUL-2024 WITH ACCEPTABLE RESULTS. BASED ON THE QC DATA PROVIDED, LEVEL 3 QC WAS ACCEPTABLE BEFORE THE EVENT. THE SAMPLE WAS SPUN FOR 5 MINUTES AT 5100 REVOLUTIONS PER MINUTE (RPM). THE SPIN TIME MAY BE SHORTER AND THE SPIN SPEED MAY BE FASTER THAN RECOMMENDED. NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE FIELD SERVICE ENGINEER (FSE) FOUND AN ISSUE WITH THE ELECTRODES. THE FSE CLEANED THE SIPPER AND VACUUM NOZZLES AND THE MIXING BOWL. SODIUM (NA) ELECTRODE CHECKS REMAINED VERY LOW. THE FSE REPLACED ALL OF THE ELECTRODES AND ADDITIONAL INSTRUMENT CHECKS WERE ACCEPTABLE. THE SERVICE ACTIONS RESOLVED THE ISSUE.

Additional Manufacturer Narrative

THE NA AND CL ELECTRODE LOT NUMBERS WITH EXPIRATION DATES WERE NOT PROVIDED.

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE RESULTS FOR 5 PATIENT SAMPLES TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. DISCREPANT RESULTS WERE PROVIDED FOR 1 PATIENT SAMPLE TESTED FOR CL ELECTRODE (CL) AND NA ELECTRODE (NA). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE THE DOCTOR QUESTIONED THEM. THE SAMPLES WERE REPEATED ON A DIFFERENT ISE ANALYZER. THE INITIAL NA RESULT WAS 154.9 MMOL/L. THE REPEAT RESULT WAS 140.1 MMOL/L. THE INITIAL CL RESULT WAS 116.9 MMOL/L. THE REPEAT RESULT WAS 104.1 MMOL/L.