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 ROCHE 9180 SODIUM ELECTRODE AND POTASSIUM ELECTRODE LOT NUMBER IS 31250347, AND THE EXPIRATION DATE WAS 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 ROCHE 9180 SODIUM ELECTRODE AND POTASSIUM ELECTRODE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE INITIAL SODIUM RESULT WAS 141 MMOL/L, AND THE INITIAL POTASSIUM RESULT WAS 1.19 MMOL/L AT 11:21. THE FIRST REPEAT SODIUM RESULT WAS 157 MMOL/L, AND THE POTASSIUM RESULT WAS 1.14 MMOL/L AT 12:31. THE SECOND REPEAT SODIUM RESULT WAS 141 MMOL/L, AND THE POTASSIUM RESULT WAS 1.11 MMOL/L AT 12:33. THE THIRD REPEAT SODIUM RESULT WAS 141 MMOL/L, AND THE POTASSIUM RESULT WAS 1.14 MMOL/L AT 12:34. THE FOURTH REPEAT SODIUM RESULT WAS 141 MMOL/L, AND THE POTASSIUM RESULT WAS 1.12 MMOL/L AT 12:36. THE FIFTH REPEAT SODIUM RESULT WAS 123 MMOL/L, AND THE POTASSIUM RESULT WAS 1.20 MMOL/L AT 12:38. THE SIXTH REPEAT SODIUM RESULT WAS 125 MMOL/L, AND THE POTASSIUM RESULT WAS 1.18 MMOL/L AT 12:40. THE SODIUM RESULT OF 141 MMOL/L WAS VALIDATED. THE CUSTOMER REPLACED THE REFERENCE ELECTRODE.