SODIUM ELECTRODE

Additional Manufacturer Narrative

THE COBAS 6000 C 501 SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE MODULE BUT WAS UNABLE TO DETERMINE THE EXACT CAUSE OF THE EVENT. HE CLEANED THE MIXING VESSELS. HE VERIFIED THE MODULE'S PERFORMANCE WITH ION-SELECTIVE ELECTRODE CHECKS, CALIBRATIONS, QCS, AND PRECISION CHECKS. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THE INITIAL REPORTER RECEIVED QUESTIONABLE SODIUM ELECTRODE RESULTS FROM PATIENT SAMPLES TESTED ON THE COBAS 6000 C (501) MODULE. AN EXAMPLE OF DISCREPANT RESULTS WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT FROM THE MODULE WAS 167 MMOL/L. THE REPEAT RESULT FROM ANOTHER C 501 MODULE WAS 143 MMOL/L. A CRITICAL FLAG IN THE MIDDLEWARE PROMPTED THE RERUN OF THE PATIENT SAMPLE. THE REPEAT RESULT WAS DEEMED CORRECT.

Additional Manufacturer Narrative

THE INVESTIGATION INCLUDED A REVIEW OF THE DATA SET PROVIDED BY THE CUSTOMER: THE CALIBRATION AND QC RESULTS WERE WITHIN THE SPECIFIED RANGES. THE ALARM TRACE DID NOT INDICATE ANY ISSUES. THE CENTRIFUGATION SETTINGS MAY BE INCORRECT BASED ON THE TUBE MANUFACTURER¿S RECOMMENDED GUIDELINES. THE CUSTOMER DID NOT REPORT ANY OTHER ISSUES AFTER THE SERVICE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM BASED ON THE INFORMATION PROVIDED. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.