NA ELECTRODE

Additional Manufacturer Narrative

THE ELECTRODE LOT NUMBER WAS B8165. THE EXPIRATION DATE WAS NOT PROVIDED. THE COBAS 6000 C 501 SERIAL NUMBER WAS (B)(6). THE FIELD SERVICE ENGINEER COULD NOT REPRODUCE THE ISSUE OR FIND A SPECIFIC CAUSE. HE REPLACED THE DEGASSER TANK, A VALVE, THE BATH SUB-ASSEMBLY, AND THE INTERNAL STANDARD BATH. THE CUSTOMER REPLACED THE POTASSIUM ELECTRODE. HE PERFORMED ISE CHECKS THAT WERE ACCEPTABLE AND THE CUSTOMER PERFORMED QC. THE CUSTOMER RECALIBRATED WITH A NEW LOT (81526901) OF INTERNAL STANDARD WHICH APPEARED TO RESOLVE THE ISSUE. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM RESULTS FROM THE COBAS 6000 C 501 MODULE. THE INITIAL RESULT WAS 134 MMOL/L AND THE REPEAT RESULT FROM ANOTHER COBAS C501 ANALYZER WAS 141 MMOL/L. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER REPLACED THE DEGASSER TANK, MULTIPLE VALVES, BATH ASSEMBLY, INTERNAL STANDARD BATH, AND OTHER VARIOUS PARTS. THE CUSTOMER REPLACED THE POTASSIUM ELECTRODE. FOR VERIFICATION, ISE CHECKS AND PRECISION WERE PERFORMED WITH ACCEPTABLE RESULTS. THE ANALYZER ALARM TRACE CONTAINED ABNORMAL PROBE SUCKING AND SAMPLE SHORT ERRORS. THESE ARE INDICATORS OF POSSIBLE POOR SAMPLE QUALITY. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THE INVESTIGATION DID NOT IDENTIFY THE SPECIFIC CAUSE OF THE EVENT. THE ISSUE APPEARED TO BE RESOLVED AFTER THE SERVICE ACTIONS.