ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE ROCHE 9180 ELECTROLYTE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE ROCHE 9180 SODIUM ELECTRODE, ROCHE 9180 POTASSIUM ELECTRODE, AND ROCHE 9180 CHLORIDE ELECTRODE RESULTS FROM SEVERAL PATIENT SAMPLES TESTED ON THE ROCHE 9180 ELECTROLYTE ANALYZER. THIS MEDWATCH IS FOR THE ROCHE 9180 SODIUM ELECTRODE ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER: (B)(6) - FOR THE ROCHE 9180 POTASSIUM ELECTRODE ASSAY. (B)(6) - FOR THE ROCHE 9180 CHLORIDE ELECTRODE ASSAY. THE REPORTER PROVIDED THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: THE HIGH NA RESULT WAS MMOL/L 144 MMOL/L. THE LOW RESULT WAS 116 MMOL/L WITH A DATA FLAG. THE HIGH K RESULT WAS MMOL/L 6.0 MMOL/L WITH A DATA FLAG. THE LOW RESULT WAS 3.9 MMOL/L. THE HIGH CL RESULT WAS MMOL/L 117 MMOL/L WITH A DATA FLAG. THE LOW RESULT WAS 103 MMOL/L.

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 ANALYZERS. 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

MEDWATCH FIELDS D. DEVICE IDENTIFICATION, G1 AND G4 PMA / 510K (PREMARKET NUMBERS) UPDATED. ON THE FIELD SERVICE ENGINEER'S INITIAL SERVICE VISIT, HE INSPECTED THE ANALYZER AND REPLACED THE REFERENCE, SODIUM, AND CHLORIDE ELECTRODES. HE ALSO PERFORMED PREVENTIVE MAINTENANCE, REPLACED THE TUBING, SYSTEM REAGENTS, MAIN BOARD, AND PRINTER. ON HIS FOLLOW-UP SERVICE VISIT, HE AGAIN REPLACED THE REFERENCE ELECTRODE. THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH THE INTERPLAY BETWEEN SPECIFIC CORE COMPONENTS WITHIN THE SYSTEM (NON-ROCHE REFERENCE ELECTRODE, SODIUM ELECTRODE, AND SYSTEM REAGENTS). THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.