SODIUM ELECTRODE

Additional Manufacturer Narrative

CALIBRATION AND QC WERE ACCEPTABLE. THE CUSTOMER USED A CENTRIFUGATION TIME OF 5 MINUTES AT "4150." BASED ON THE SAMPLE TUBES USED, THIS SPIN TIME IS SHORTER THAN RECOMMENDED (10 MINUTES), AND THE SPIN SPEED MAY BE FASTER THAN RECOMMENDED. THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE INSTRUMENT OPERATING PROPERLY. THE CUSTOMER COMPLAINED OF NO FURTHER ISSUES, AND NO ADDITIONAL INFORMATION WAS PROVIDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THE COBAS PRO ISE ANALYZER SERIAL NUMBER WAS (B)(6).

Description of Event or Problem

THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS PRO ISE ANALYTICAL UNIT. APPROXIMATELY 200 PATIENT SAMPLES WERE REPEATED, AND 70 CORRECTED REPORTS WERE ISSUED. DISCREPANT RESULTS WERE PROVIDED FOR 2 PATIENT SAMPLES TESTED FOR SODIUM ELECTRODE (NA). PATIENT 1 INITIAL RESULT WAS 140 MEQ/L. THE REPEAT RESULT WAS 132.6 MEQ/L. PATIENT 2 INITIAL RESULT WAS 141 MEQ/L. THE REPEAT RESULT WAS 134.3 MEQ/L. THE HIGH RESULTS WERE QUESTIONED, AND THE SAMPLES WERE REPEATED ON A DIFFERENT COBAS PRO ISE ANALYZER. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.