ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6). THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE AND INSPECTED THE INSTRUMENT: REMOVED THE TUBING HARNESS, ELECTRODES, NEEDLE AND WASH PORT. THE INSTRUMENT SURFACES WERE THOROUGHLY CLEANED. THE FSE NOTED EVIDENCE OF LEAKAGE AS CRYSTALS WERE OBSERVED UNDERNEATH THE CHASSIS. THE CRYSTAL BUILDUP WAS CLEANED UP FROM THE EXTERNAL SURFACES. THE MAIN BOARD WAS REMOVED AND THE BACK OF VALVES WERE INSPECTED. EVIDENCE OF LEAKAGE WAS OBSERVED AND SOME VALVES WERE RUSTY. THE FSE CLEANED THE INTERNAL CRYSTAL BUILDUP AND REPLACED THE VENT AND VALVE LINE. PREVENTIVE MAINTENANCE WAS PERFORMED. THE INSTRUMENT INITIALLY CALIBRATED FOR SODIUM AND CHLORIDE BUT K+ FAILED. THE FSE PERFORMED ADDITIONAL CLEANING CYCLES AND K+ CALIBRATED OK AFTERWARDS. THREE LEVELS OF QC WERE ACCEPTABLE. THE FSE RAN QC AGAIN AND K+ WAS OUT OF RANGE HIGH FOR LEVEL 3. THE INSTRUMENT WAS CALIBRATED AGAIN AND QC WAS ACCEPTABLE. THE INSTRUMENT WAS PUT BACK IN SERVICE WITH A NEW ELECTRODE. THE CUSTOMER HAS NOT HAD ANY FURTHER ISSUES SINCE THE SERVICE VISIT.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR POTASSIUM (K+) ON AN ELECTROLYTE ANALYZER ISE 9180 INSTRUMENT COMPARED TO AN ABL 90 FLEX INSTRUMENT. THE RESULT FROM THE ISE 9180 INSTRUMENT WAS 3.5 MMOL/L. THE SAME SAMPLE WAS RUN ON AN ABL 90 FLEX INSTRUMENT AND THE RESULT WAS 5.2 MMOL/L. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE K+ ELECTRODE LOT NUMBER WAS 21584549. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER STATED QC HAD BEEN PERFORMED DAILY AND HAD PASSED. AFTER THIS EVENT, QC WAS RUN AND THE RESULTS WERE LOW FOR K+. THE CUSTOMER CHANGED THE FLUID PACK AND QC WAS BACK WITHIN THE ACCEPTABLE RANGE. AFTER MAKING THIS CHANGE, THE CUSTOMER COMPARED 2 PATIENT SAMPLES FROM THE ISE 9180 TO THE ABL 90 FLEX INSTRUMENT AND THE RESULTS WERE COMPARABLE TO ONE ANOTHER. ON (B)(6) 2019 THE CUSTOMER HAD ISSUES WITH QC RESULTS FOR K+ NOT PASSING AGAIN AND THE K+ PARAMETER COULD NOT BE CALIBRATED AT ALL.

Additional Manufacturer Narrative

THE CUSTOMER RETURNED ELECTRODES AND REAGENT PACKS FOR INVESTIGATION. THE CUSTOMER¿S OBSERVATION COULD NOT BE REPRODUCED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.