ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE ROOT CAUSE OF THE ISSUE WAS RELATED TO A REFERENCE ELECTRODE MANUFACTURED BY DIAMOND DIAGNOSTICS (DD REF ELECTRODE) USED WITH THE 9180 ELECTROLYTE ANALYZER. THE REFERENCE ELECTRODE USED (DD REF ELECTRODE) IS COVERED BY A ROCHE INITIATED RECALL. CUSTOMERS USING THE DD REF ELECTRODE WERE INSTRUCTED TO IMMEDIATELY STOP USING SODIUM (NA) RESULTS FROM THEIR 9180 ANALYZER. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE ROCHE REFERENCE ELECTRODE AND REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.

Additional Manufacturer Narrative

THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE REQUESTED, BUT NOT PROVIDED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE SODIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 119 MMOL/L. WHEN REPEATED ON THE ANALYZER, THE RESULT IS THE SAME. THE SAMPLE WAS REPEATED ON A COULTER ANALYZER AND THE RESULT WAS 136 MMOL/L. IT WAS ASKED, BUT IT IS NOT KNOWN IF THE SAME SAMPLE WAS USED FOR THE ROCHE 9180 AND COULTER MEASUREMENTS. THE CUSTOMER STATED ANOTHER SAMPLE WAS COLLECTED FROM THE PATIENT AND THE SODIUM RESULT FROM THIS SAMPLE WAS NORMAL. ADDITIONAL SODIUM MEASUREMENTS OF 122 MMOL/L, 122 MMOL/L, AND 118.0 MMOL/L MEASURED ON (B)(6) 2025 WERE PROVIDED. IT WAS ASKED, BUT IT IS NOT KNOWN IF THESE WERE VALUES FROM THE SAME COMPLAINED PATIENT SAMPLE OR IF THESE WERE MEASUREMENTS OF OTHER PATIENT SAMPLES.

Additional Manufacturer Narrative

QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. INITIAL FINDINGS SUGGEST A PROBLEM LIKELY STEMMING FROM THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM, ALONG WITH POTENTIAL DEFICIENCIES IN THE INSTRUMENT'S OPERATION.

Additional Manufacturer Narrative

THE REPEAT SODIUM (NA) VALUE OF 136 MMOL/L OBTAINED FROM THE COULTER ANALYZER WAS MEASURED FROM THE SAME SAMPLE THAT WAS INITIALLY TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER. THE ADDITIONAL NA MEASUREMENTS OF 122 MMOL/L, 122 MMOL/L, AND 118.0 MMOL/L THAT WERE MEASURED ON (B)(6) 2025, WERE FROM DIFFERENT SAMPLES FROM DIFFERENT PATIENTS HAVING THE SAME ISSUE OF LOW NA RESULTS, BUT THEY GENERATED NORMAL RESULTS WHEN TESTED ON COULTER ANALYZER. THE CUSTOMER REPLACED THE NA ELECTRODE, THE REFERENCE ELECTRODE, AND THE REFERENCE ELECTRODE HOUSING. THE INSTRUMENT UNDER OBSERVATION. THE INVESTIGATION IS ONGOING.