NA ELECTRODE

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6) . THE CUSTOMER STATED THAT THEIR CALIBRATION AND QC WAS ACCEPTABLE. THE CUSTOMER REPLACED THE ISE ELECTRODES AND PERFORMED AN ISE PRECISION TEST SUCCESSFULLY. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE CUSTOMER RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE GEN.2 ISE INDIRECT FOR NA AND CL RESULTS FOR 1 PATIENT PLASMA SAMPLE ON A COBAS 6000 C (501) MODULE. THIS MEDWATCH WILL COVER NA REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CL RESULTS THE INITIAL NA RESULT WAS 119 MMOL/L AND THE INITIAL CL RESULT WAS 118.2 MMOL/L. THE CUSTOMER QUESTIONED THE INITIAL RESULTS AS THEY WERE DEEMED CRITICAL AND WAS PROMPTED TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER C501 ANALYZER AND THE NA RESULT WAS 136 MMOL/L AND THE CL RESULT WAS 102 MMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.