ISE 9180

Additional Manufacturer Narrative

THE CUSTOMER PROVIDED DATA FOR THREE PATIENTS WITH QUESTIONABLE ION SELECTIVE ELECTRODE POTASSIUM RESULTS, OF WHICH TWO HAD DISCREPANT RESULTS THAT WERE REPORTED OUTSIDE THE LABORATORY. THE SAMPLES WERE TESTED ON (B)(6) 2014. THE SAMPLES WERE REPEATED ON ANOTHER 9180 ANALYZER. THE FIRST PATIENT'S INITIAL POTASSIUM RESULT WAS 7.35 MMOL/L. THE REPEAT RESULT WAS 8.2 MMOL/L. THE SECOND PATIENT'S INITIAL POTASSIUM RESULT WAS 4.5 MMOL/L. THE REPEAT RESULT WAS 5.0 MMOL/L. INFORMATION ON WHETHER THE PATIENTS WERE ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE POTASSIUM ELECTRODE LOT NUMBER WAS 21522761. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED.

Description of Event or Problem

THE CUSTOMER ALLEGED THEY RECEIVED VERY LOW ION SELECTIVE ELECTRODE SODIUM AND POTASSIUM RESULTS ON THEIR ISE 9180 ANALYZER. THE CUSTOMER PROVIDED DATA FOR ONE DISCREPANT SODIUM RESULT THAT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S INITIAL SODIUM RESULT WAS 95 MMOL/L. THE REPEAT RESULT WAS 109 MMOL/L. THE PATIENT WAS NOT ADVERSELY AFFECTED BY THIS EVENT. THE SODIUM ELECTRODE LOT NUMBER WAS REQUESTED BUT NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED AND CLEANED THE ELECTRODES, NEEDLE, AND WASH PORT. HE TESTED THE ELECTRODES AND FOUND VARIATIONS. HE PERFORMED CALIBRATION. HE RAN SAMPLES AND FOUND VARIATIONS IN THE SODIUM AND POTASSIUM RESULTS. IT WAS NOTED THE CUSTOMER WAS NOT PERFORMING QUALITY CONTROL ON THE ANALYZER TO CHECK THE PERFORMANCE OF THE SYSTEM.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Additional Manufacturer Narrative

A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT NOTED THE CUSTOMER DID NOT RUN QUALITY CONTROL PRIOR TO TESTING THE SAMPLES. IT WAS NOTED THE SODIUM AND POTASSIUM HAD BEEN ON BOARD THE ANALYZER FOR OVER A YEAR AND WERE PASSED THEIR ON BOARD TIMES. QUALITY CONTROL VERIFICATION BY THE CUSTOMER SHOULD HAVE INFORMED THEM OF THE STATE OF THE ELECTRODES.

Additional Manufacturer Narrative

MANUFACTURING SITE NAME WAS UPDATED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE SODIUM ELECTRODE LOT NUMBER WAS 21522955.