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 THE SODIUM (NA) 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.

Additional Manufacturer Narrative

THE ELECTRODE SERIAL NUMBERS AND THEIR EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED. THE EVENT OCCURRED AFTER THE CUSTOMER REPLACED THE NEW SODIUM ELECTRODE AND REFERENCE HOUSING WITH A NON-ROCHE REFERENCE ELECTRODE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE AND POTASSIUM ELECTRODE RESULTS FROM PATIENT SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER. THE FOLLOWING ARE EXAMPLES OF DISCREPANT RESULTS: THE INITIAL SODIUM RESULT WAS 109 MMOL/L WITH A DATA FLAG. THE REPEAT RESULT WAS 135 MMOL/L WITH A DATA FLAG. A REPEAT RESULT OF 107 MMOL/L WITH A DATA FLAG WAS ALSO REPORTED. IT IS NOT CLEAR IF THE FOLLOWING RESULTS ARE FROM THE SAME PATIENT SAMPLE: THE INITIAL POTASSIUM RESULT WAS 3.7 MMOL/L. THE REPEAT RESULT WAS 4.2 MMOL/L.

Additional Manufacturer Narrative

THE CUSTOMER CONFIRMED THAT THE REPORTED RESULTS WERE FROM THE SAME PATIENT SAMPLE. THE INITIAL RESULTS WERE OBTAINED WITHOUT A CALIBRATION, WHILE THE REPEAT RESULTS WERE OBTAINED AFTER A CALIBRATION. THE INVESTIGATION NOTED THAT THE EVENT OCCURRED AFTER THE CUSTOMER INSTALLED A NON-ROCHE REFERENCE ELECTRODE. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH THE INTERACTION OF THE NON-ROCHE REFERENCE ELECTRODE, ROCHE SODIUM ELECTRODE, CALIBRATOR, AND THE ANALYZER. PRODUCT LABELING STATES, "AFTER INSTALLING A NEW ELECTRODE, DAILY MAINTENANCE, CALIBRATION, AND QC MEASUREMENTS ON 3 LEVELS HAVE TO BE PERFORMED TO VERIFY THE PERFORMANCE OF THE ELECTRODE."