NA ELECTRODE

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S COBAS PRO ISE ANALYTICAL UNIT IS (B)(6). THE INVESTIGATION IS ONGOING. THE FIELD SERVICE ENGINEER (FSE) INVESTIGATED THE EVENT AND DETERMINED THAT THE CALIBRATIONS AND QCS WERE VALID THAT IT WAS A SINGLE QUESTIONABLE PATIENT SAMPLE RESULT AND THAT ALL THE OTHER RESULTS HAD NO ISSUES. THE CUSTOMER STATED THAT THEY SUSPECTED A PATIENT SAMPLE ISSUE. HE THEN MANUALLY CLEANED AND VERIFIED THE ION-SELECTIVE ELECTRODE (ISE) UNIT AND ITS ADJUSTMENTS AND PERFORMED A DAILY WASH RACK, ISE CHECKS, CALIBRATIONS, AND QCS. HE VERIFIED THAT THE MODULE WAS PERFORMING WITHIN SPECIFICATIONS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED A QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULT FROM ONE PATIENT SAMPLE TESTED ON THE COBAS PRO ISE ANALYTICAL UNIT THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULT FROM A SECOND PATIENT SAMPLE WAS DIFFERENT PROMPTING THE RERUN OF THE INITIAL PATIENT SAMPLE. THE INITIAL NA RESULT WAS 112.9 MMOL/L. THE REPEAT RESULT WAS 135.3 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.