ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE MEDWATCH SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. ADDITIONAL INFORMATION WAS REQUESTED FOR INVESTIGATION BUT WAS NOT PROVIDED. IT IS UNKNOWN IF THE REFERENCE ELECTRODE AND HOUSING USED ON THE INSTRUMENT ARE MANUFACTURED BY DIAMOND DIAGNOSTICS OR BY ROCHE. IT IS UNKNOWN IF THE FAILED QC HAPPENED BEFORE OR AFTER THE CLAIMED DISCREPANT RESULT. IN CASE OF FAILED QC, NO PATIENT SAMPLES SHOULD BE MEASURED FOR DIAGNOSTIC PURPOSES. THE ROOT CAUSE OF THE ISSUE IS THOUGHT TO BE 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 ANALYZERS. 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. DUE TO THE LACK OF INFORMATION AND THE FAILED QC, IT CANNOT BE CONFIRMED. THEREFORE, THE INVESTIGATION DETERMINED THAT THERE WAS NO PRODUCT ISSUE FOUND.

Additional Manufacturer Narrative

THE ROCHE 9180 ELECTROLYTE ANALYZER SERIAL NUMBER IS (B)(6). THE CUSTOMER REPORTED HAVING ISSUES CALIBRATING THE SODIUM ELECTRODE. DURING A SERVICE VISIT, A FIELD SERVICE ENGINEER (FSE) PERFORMED CLEANINGS ON THE FLUID PATH AND ELECTRODES, AND PERFORMED DAILY MAINTENANCE, BUT THE SAME ISSUE OF THE SODIUM ELECTRODE CALIBRATION RECURRED. A NEW SODIUM ELECTRODE WAS INSTALLED AND CALIBRATED. IT WAS REPORTED THAT THE CONTROL VALUES WERE VERY LOW ON THE DAY OF THE EVENT. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE RESULT FROM THE ROCHE 9180 ELECTROLYTE ANALYZER FOR ONE PATIENT. THE INITIAL RESULT WAS 109 MMOL/L, AND THE REPEAT RESULT AT ANOTHER LAB WITH AN UNKNOWN ANALYZER WAS 138 MMOL/L. THE CUSTOMER SENT THE PATIENT TO ANOTHER LAB TO CONFIRM AFTER RECEIVING A LOW INITIAL RESULT.