9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE CUSTOMER STATED THAT QC WAS ACCEPTABLE. THE CUSTOMER STOPPED USING THE ISE 9180 ELECTROLYTE ANALYZER. DESPITE SEVERAL REMINDERS, THE CUSTOMER DID NOT PROVIDE THE REQUESTED DATA FOR FURTHER INVESTIGATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE NA AND CL ELECTRODES' LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE CUSTOMER MENTIONED THAT THE NA RESULTS WAS DEPRECIATING OVER TIME. THE ISSUE WAS TEMPORARILY SOLVED BY THE CUSTOMER RESTARTING AND RECALIBRATING THE SYSTEM. DAILY MAINTENANCE AND CLEANING WAS PERFORMED ACCORDING TO SPECIFICATIONS. ON 08-NOV-2024 THE FIELD SERVICE ENGINEER (FSE) ADVISED THE CUSTOMER TO CLEAN THE SAMPLE PROBE/NEEDLE. ON 10-NOV-2024 THE FSE REPLACED THE PUMP TUBE AND CLEANED THE SAMPLE NEEDLE AND THE ELECTRODES. AND ON 13-NOV-2024 THE FSE CHECKED THE FLUIDICS AND THEY WERE ACCEPTABLE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE ISE RESULTS FOR 3 PATIENTS' SERUM SAMPLES TESTED ON AN 9180 ELECTROLYTE ANALYZER. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA), AND POTASSIUM (K). SAMPLE 1: NA: INITIAL RESULT: 139 MMOL/L. REPEAT RESULT: 114 MMOL/L. K: INITIAL RESULT: 4.1 MMOL/L. REPEAT RESULT: 4.6 MMOL/L. SAMPLE 2 AND SAMPLE 3 WERE TESTED ON (B)(6)2024. SAMPLE 2: NA: INITIAL RESULT: 114 MMOL/L. REPEAT RESULT: 139 MMOL/L. SAMPLE 3: K: INITIAL RESULT: 4.5 MMOL/L. REPEAT RESULT: 5.5 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE INITIAL RESULTS WERE DEEMED TO BE CORRECT.