ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE 9180 ELECTROLYTE ANALYZER 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 SODIUM ELECTRODE AND CHLORIDE ELECTRODE ON A 9180 ELECTROLYTE ANALYZER. THIS MEDWATCH WILL APPLY TO THE CHLORIDE ELECTRODE. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE SODIUM ELECTRODE. THE SAMPLE INITIALLY RESULTED IN A NA VALUE OF 133 MMOL/L WITH A DATA FLAG AND IT REPEATED AS 113 MMOL/L WITH A DATA FLAG. THE SAMPLE INITIALLY RESULTED IN A CL VALUE OF 98 MMOL/L AND IT REPEATED AS 146 MMOL/L WITH A DATA FLAG.

Additional Manufacturer Narrative

NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS AN OUTPATIENT.

Additional Manufacturer Narrative

THE MAIN PRINTED CIRCUIT BOARD AND FLUID PACK WERE REPLACED ON AN UNKNOWN DATE. THE FIELD SERVICE ENGINEER PERFORMED MAINTENANCE ON THE ANALYZER. A NEW REFERENCE ELECTRODE AND REFERENCE ELECTRODE HOUSING WERE INSTALLED. REPLACING THE ELECTRODES RESOLVED THE ISSUE. BASED ON PHOTOS OF THE ELECTRODES, NO DEFECTS WERE OBSERVED. THERE WAS NO EVIDENCE OF LEAKAGE OR CRYSTALLIZATION. THE ANALYZER ELECTRODES WERE REQUESTED FOR INVESTIGATION, BUT COULD NOT BE PROVIDED. A REVIEW OF THE INSTRUMENT ERROR REPORT SHOWED A POWER FAIL ERROR ON 08-DEC-2024, A CALIBRATION ERROR ON 10-DEC-2024, AND AN ELECTRODE ERROR ON 12-DEC-2024. POWER FAILURES WERE OBSERVED BOTH BEFORE AND AFTER THE EVENT. IT WAS OBSERVED THAT DAILY MAINTENANCE WAS NOT PERFORMED DAILY AS REQUIRED. ON 26-DEC-2024, CALIBRATION FAILED FOR ALL PARAMETERS. THE CUSTOMER DID NOT SET UP THE QUALITY CONTROL LIMITS CORRECTLY ON THE ANALYZER, SO THE LIMITS FOR THE QC MEASUREMENTS IS UNKNOWN. A REVIEW OF NA ELECTRODE PRODUCTION DATA SHOWED NO IRREGULARITIES AT THE TIME OF PRODUCTION. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. MEDWATCH FIELDS D1, D2, D4, G1, AND G4 HAVE BEEN UPDATED.