NA ELECTRODE

Additional Manufacturer Narrative

THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE ELECTRODES WERE REPLACED, WASH RACKS WERE RERUN, AND CALIBRATION AND QC WERE PERFORMED. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE NA ELECTRODE RESULTS FOR 37 PATIENT SAMPLES ON A COBAS PRO ISE ANALYTICAL UNIT. PLEASE REFER TO THE ATTACHMENT "(B)(6)" FOR EXAMPLES OF QUESTIONABLE PATIENT RESULTS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY AND CORRECTED REPORTS WERE SENT. THE REPEATED RESULTS WERE OBTAINED ON ANOTHER MODULE AND WERE BELIEVED TO BE CORRECT. THE SAMPLES WERE REPEATED DUE TO FAILED QUALITY CONTROLS.

Additional Manufacturer Narrative

CALIBRATION AND QC WERE ACCEPTABLE. A GENERAL REAGENT ISSUE WAS EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.