ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE SODIUM ELECTRODE LOT NUMBER AND EXPIRATION DATE WERE NOT PROVIDED. QC WAS ACCEPTABLE. THE CUSTOMER STATED THAT THE CALIBRATION WAS ACCEPTABLE. THE INVESTIGATION DETERMINED THAT 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 RESULTS FROM THEIR 9180 ANALYZER. THE AFFECTED REFERENCE ELECTRODE WAS NOT DISTRIBUTED IN THE UNITED STATES. CUSTOMERS IN THE UNITED STATES USE THE ROCHE REFERENCE ELECTRODE AND THE REFERENCE ELECTRODE HOUSING. NO FURTHER ACTION IS NEEDED FOR CUSTOMERS IN THE UNITED STATES.

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR SODIUM ON A ROCHE 9180 ELECTROLYTE ANALYZER. INITIAL RESULT: 125 MMOL/L. THE CUSTOMER OBSERVED CRYSTALLIZATION AROUND THE REFERENCE ELECTRODE AND NOTICED THAT THE INITIAL RESULT DID NOT CORRELATE WITH THE PATIENT'S CONDITION, AND REPEATED THE SAMPLE. REPEAT RESULT: 140 MMOL/L (TESTED ON A COBAS PURE INSTRUMENT). THE REPEAT RESULT WAS DEEMED TO BE CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY.