ROCHE 9180 SODIUM ELECTRODE

Additional Manufacturer Narrative

SECTION D, DEVICE IDENTIFICATION WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE 9180 ELECTROLYTE ANALYZER SERIAL NUMBER WAS (B)(6). CALIBRATION AND QC WERE ACCEPTABLE. TRENDING WAS PERFORMED ON THIS TYPE OF COMPLAINT AND NO ABNORMAL TREND WAS IDENTIFIED. THE ISSUE WAS RESOLVED BY REPLACING THE REFERENCE ELECTRODE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE NA ELECTRODE LOT NUMBER WAS 31243247 WITH AN INSTALL BEFORE DATE OF 04-APR-2025. THE ELECTRODES WERE REQUESTED FOR INVESTIGATION; HOWEVER, THEY WERE DISCARDED BY THE CUSTOMER AND ARE NO LONGER AVAILABLE. THE FIELD APPLICATION SPECIALIST (FAS) INDICATED THAT THE INSTRUMENT IS WORKING FINE WITH NEW REFERENCE ELECTRODES. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER COMPLAINED OF DISCREPANT LOW RESULTS FOR 1 PATIENT SAMPLE TESTED FOR SODIUM (NA) ON A (B)(6) ELECTROLYTE ANALYZER. THE INITIAL RESULT WAS 109 MMOL/L WITH A DATA FLAG. THE CUSTOMER PERFORMED CLEANING AND CONDITIONING AND THE REPEAT RESULT WAS 138 MMOL/L. THE CUSTOMER REPEATED THE SAMPLE AND THE RESULT WAS AGAIN 109 MMOL/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULT OF 138 MMOL/L WAS BELIEVED TO BE CORRECT BASED ON THE PATIENT¿S PREVIOUS RESULTS.

Additional Manufacturer Narrative

G1 CONTACT OFFICE-MANUFACTURING SITE WAS UPDATED.