ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE CALIBRATION AND QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE ELECTRODES AND PERFORMED SEVERAL WASHES. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 3 PATIENT SERUM SAMPLES ON A 9180 ELECTROLYTE ANALYZER. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL NA RESULT OF 113 MMOL/L. THE SAMPLE WAS REPEATED AND THE NA RESULT WAS 137 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL NA RESULT OF 112 MMOL/L. THE SAMPLE WAS REPEATED AND THE NA RESULT WAS 137 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. ON (B)(6) 2024, SAMPLE 3 HAD AN INITIAL NA RESULT OF 116 MMOL/L. THE SAMPLE WAS REPEATED AND THE NA RESULT WAS 169 MMOL/L.

Additional Manufacturer Narrative

SECTION D, DEVICE IDENTIFICATION, WAS UPDATED. RELEVANT FIELDS OF SECTIONS D AND G WERE UPDATED. THE SODIUM ELECTRODE LOT NUMBER WAS 31240447 WITH AN EXPIRATION DATE OF 20-SEP-2024. THE SODIUM ELECTRODE LOT NUMBER 31240447 WAS RECEIVED FOR INVESTIGATION. THE ELECTRODE HAD SUFFICIENT INNER FLUIDS AND WAS NOT DAMAGED. TWO REFERENCE ELECTRODES WERE ALSO SUBMITTED FOR INVESTIGATION (LOTS 2307138 AND 2403139). THE CUSTOMER USED REFERENCE ELECTRODE LOT NUMBER 2403139. CRYSTALLIZATION WAS OBSERVED AROUND THE NIPPLES FOR BOTH REFERENCE ELECTRODES. CALIBRATION AND QC WERE ACCEPTABLE. INSTRUMENT MAINTENANCE WAS LAST PERFORMED ON 04-SEP-2024. QC AND CALIBRATION WERE PERFORMED USING THE CUSTOMER'S ELECTRODES ON TWO ROCHE 9180 ELECTROLYTE ANALYZERS AT THE INVESTIGATION SITE. THE INVESTIGATION NAMED THE SODIUM ELECTRODE WITH LOT NUMBER 31240447 AND REFERENCE ELECTRODE LOT NUMBER 2403139 (PAIR 2), AND THE SODIUM ELECTRODE WITH LOT NUMBER 31240447 AND REFERENCE ELECTRODE LOT NUMBER 2307138 (PAIR 1). MULTIPLE QC TESTS WERE PERFORMED WITH EACH PAIR AT VARIOUS TIMES AFTER CALIBRATING EACH INSTRUMENT. ALL RESULTS WERE ACCEPTABLE. THE INVESTIGATION PERFORMED SODIUM (NA) TESTS USING PAIR 1 AND PAIR 2 ON EACH INSTRUMENT USED AT THE INVESTIGATION SITE. WHEN USING PAIR 2, THE INVESTIGATION REPRODUCED THE DISCREPANT RESULTS OBSERVED BY THE CUSTOMER: THE NA RESULT FROM ONE INSTRUMENT WAS 113 MMOL/L, AND THE RESULT FROM THE OTHER INSTRUMENT WAS 121 MMOL/L. THE SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, THE INVESTIGATION DETERMINED THAT THE EVENT WAS LIKELY DUE TO AN ISSUE BETWEEN THE COMPONENTS USED ON THE INSTRUMENT (THE REFERENCE ELECTRODE AND THE NA ELECTRODE).