NA ELECTRODE

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER (FSE) VERIFIED THE ANALYZER'S PERFORMANCE WITH PRECISION AND ION-SELECTIVE ELECTRODE CHECKS. THE CALIBRATION RESULTS WERE WITHIN SPECIFICATIONS. THE QCS WERE WITHIN THE -2 STANDARD DEVIATIONS AND WERE ACCEPTABLE. THERE WAS NO INDICATION OF A PERFORMANCE ISSUE WITH THE REAGENT. THE ALARM TRACE DID NOT INDICATE ANY ISSUES. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER SERVICE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS PRO ISE ANALYTICAL UNIT IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER BUT COULD NOT IDENTIFY A CAUSE FOR THE EVENT. HE NOTED THAT THE ION-SELECTIVE ELECTRODE (ISE) UNIT WAS OPERATIONAL. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE NA ELECTRODE RESULTS FROM APPROXIMATELY SIXTY PATIENT SAMPLES TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT. THE REPORTER STATED THAT SOME RESULTS WERE FLAGGED IN THEIR LABORATORY INFORMATION SYSTEM AND THE DIFFERENCE BETWEEN THE PATIENT SAMPLES' INITIAL AND REPEAT RESULTS WAS APPROXIMATELY 7 MMOL/L. ONE EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED: THE INITIAL NA RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. THE PHYSICIAN QUESTIONED TWO CRITICAL LOW RESULTS PROMPTING THE RERUN OF THE PATIENT SAMPLES. THE REPEAT RESULT WAS DEEMED CORRECT.