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. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE 9180 INSTRUMENT IS (B)(6). 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 ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE SAMPLE WAS TESTED FIVE TIMES, RESULTING IN THE FOLLOWING SODIUM VALUES: 139 MMOL/L, 138 MMOL/L, 138 MMOL/L, 138 MMOL/L, AND 138 MMOL/L. THE SAMPLE WAS TESTED TWO ADDITIONAL TIMES ON A BACKUP 9180 INSTRUMENT, RESULTING IN SODIUM VALUES OF 114 MMOL/L WITH A DATA FLAG AND 112 MMOL/L WITH A DATA FLAG. THESE REPEAT VALUES WERE APPROPRIATE FOR THE PATIENT'S CLINICAL CONDITION.