NA ELECTRODE

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). CALIBRATION WAS LAST PERFORMED ON THE DAY OF THE EVENT. THE QC RECOVERY DATA PROVIDED WAS ACCEPTABLE. THE ALARM TRACE DID NOT CONTAIN A CONSPICUOUS EVENT. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE NA ELECTRODE AND INSPECTED ALL OTHER ELECTRODES AND CABLE CONNECTIONS. THE FSE PERFORMED A REAGENT PRIME, ISE CHECKS, AND A 21 CUP PRECISION CHECK SUCCESSFULLY. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA RESULTS FOR 4 PATIENT SAMPLES ON A COBAS 6000 C (501) MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AS QC PERFORMED AFTER THE INITIAL PATIENT SAMPLE RUN WAS OUT OF THE ACCEPTABLE RANGE. FOR SAMPLE 1, THE INITIAL RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. FOR SAMPLE 2, THE INITIAL RESULT WAS 132 MMOL/L. THE REPEAT RESULT WAS 139 MMOL/L. FOR SAMPLE 3, THE INITIAL RESULT WAS 131 MMOL/L. THE REPEAT RESULT WAS 138 MMOL/L. FOR SAMPLE 4, THE INITIAL RESULT WAS 131 MMOL/L. THE REPEAT RESULT WAS 137 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. THE CUSTOMER ALSO REPEATED THE SAMPLES ON ANOTHER ANALYZER AND THE RESULTS MATCHED THE REPEAT RESULTS.