ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE NA, K, AND CL ELECTRODES' LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. QC WAS WITHIN THE ASSIGNED RANGES ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE ION-SELECTIVE ELECTRODE (ISE) RESULTS FOR 3 PATIENTS¿ SAMPLES TESTED ON A ROCHE 9180 ELECTROLYTE ANALYZER. RESULTS FOR THE FOLLOWING TESTS WERE AFFECTED: SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL). SAMPLE 1: NA: INITIAL RESULT: 145.3 MMOL/L. REPEAT RESULT: 138.6 MMOL/L. K: INITIAL RESULT: 1.73 MMOL/L. REPEAT RESULT: 5.47 MMOL/L. SAMPLE 2: CL: INITIAL RESULT: 124.1 MMOL/L. REPEAT RESULT: 110.1 MMOL/L. SAMPLE 3: NA: INITIAL RESULT: 152.0 MMOL/L. REPEAT RESULT: 139.1 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AND REPEATED THE SAMPLES. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.

Additional Manufacturer Narrative

THE CUSTOMER WAS USING AN EXPIRED CHLORIDE ELECTRODE AT THE TIME OF THE EVENT (EXPIRATION DATE: (B)(6) 2025. THERE IS NO EVIDENCE OF INSTRUMENT MALFUNCTION AS THE CALIBRATIONS AND QCS WERE ACCEPTABLE. THE CHLORIDE ELECTRODE WAS SLIGHTLY ABOVE THE VALID RANGE, AND IT WAS REPLACED. THE SERVICE LOG SHOWED OBSTRUCTION ERRORS ON 09-JUN-2025, AND STANDARD ERRORS ON 09-JUN-2025 AND 10-JUN-2025. THE CUSTOMER USES A NON-ROCHE REFERENCE ELECTRODE FOR THE ROCHE REFERENCE ELECTRODE HOUSING. THE FIELD SERVICE ENGINEER CLEANED AND CONDITIONED THE INSTRUMENT, REPLACED THE POTASSIUM AND EXPIRED CHLORIDE ELECTRODES, AND REPLACED THE STANDARD AND REFERENCE SOLUTIONS. THE INSTRUMENT WAS MONITORED, AND NO FURTHER ISSUES WERE OBSERVED. THE CAUSE OF THE EVENT WAS CONSISTENT WITH A PREANALYTIC ISSUE AT THE CUSTOMER SITE. PREANALYTICS ARE WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.