9180 ELECTROLYTE ANALYZER

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH THE NA ELECTRODE ON A 9180 ELECTROLYTE ANALYZER. THE FIRST PATIENT SAMPLE ALSO HAD DISCREPANT RESULTS WHEN TESTED WITH THE K ELECTRODE. THE USER DECIDED TO REPEAT THE AFFECTED SAMPLES SINCE THE INITIAL VALUES DID NOT MATCH PREVIOUS MEASUREMENTS OF THE PATIENTS. THE FIRST SAMPLE INITIALLY RESULTED IN A NA VALUE OF 152 MMOL/L ACCOMPANIED BY A DATA FLAG AND REPEATED AS 143 MMOL/L. THIS SAMPLE INITIALLY RESULTED IN A K VALUE OF 12.2 MMOL/L ACCOMPANIED BY A DATA FLAG AND REPEATED AS 4.3 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A NA VALUE OF 154 MMOL/L ACCOMPANIED BY A DATA FLAG ON (B)(6) 2022 AND REPEATED AS 143 MMOL/L ON (B)(6) 2022. THE THIRD SAMPLE INITIALLY RESULTED IN A NA VALUE OF 124 MMOL/L ACCOMPANIED BY A DATA FLAG ON (B)(6) 2022 AND REPEATED AS 140 MMOL/L ON (B)(6) 2022. THE FOURTH SAMPLE INITIALLY RESULTED IN A NA VALUE OF 137 MMOL/L ON (B)(6) 2022 AND REPEATED AS 129 MMOL/L ACCOMPANIED BY A DATA FLAG ON (B)(6) 2022. THE NA ELECTRODE LOT NUMBER WAS 21512762 WITH AN INSTALL-BY DATE OF (B)(6) 2022. THE K ELECTRODE LOT NUMBER WAS 21513747 WITH AN INSTALL-BY DATE OF (B)(6) 2022.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) FOUND CONDENSATION AND BUBBLES ON THE ELECTRODES. THE BUBBLES WERE REMOVED FROM THE ELECTRODES. AFTERWARD, THE FSE PERFORMED DAILY MAINTENANCE, RAN QC, AND PERFORMED REPEATABILITY TESTING. THE NA ELECTRODE LOT NUMBER WAS 21512762 WITH AN INSTALL-BY DATE OF 04-MAR-2022. THIS ELECTRODE WAS INSTALLED ON THE INSTRUMENT ON 16-NOV-2021. THE ELECTRODE WAS VALID FOR USE UNTIL 02-AUG-2022. THE EVENT OCCURRED ON 30-JUN-2022. THE NA ELECTRODE WAS VALID AT THE TIME OF THE EVENT. THE K ELECTRODE LOT NUMBER WAS 21513747 WITH AN INSTALL-BY DATE OF 01-APR-2022. THIS ELECTRODE WAS INSTALLED ON THE INSTRUMENT ON 16-NOV-2021. THE ELECTRODE WAS VALID FOR USE UNTIL 17-MAY-2022. THE EVENT OCCURRED ON 30-JUN-2022. AS SUCH, THE K ELECTRODE WAS INVALID AT THE TIME OF THE EVENT. THE CUSTOMER USED SAMPLE TUBES WITH A GEL SEPARATOR. SERUM-SEPARATED TUBES CAN CONTAIN SPRAY-COATED SILICA. PRODUCT LABELING STATES: "DO NOT USE SAMPLING CONTAINERS CONTAINING SILICONE." THE SAMPLE TUBE USED COULD AFFECT THE NA RESULTS. CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.