ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

Additional Manufacturer Narrative

UNIQUE IDENTIFIER (UDI)# (B)(4). THE EVENT OCCURRED IN: (B)(6).

Description of Event or Problem

THE CUSTOMER RECEIVED QUESTIONABLE ISE INDIRECT NA FOR GEN.2 RESULTS FOR 3 PATIENT SAMPLES ON A ROCHE 9180 ELECTROLYTE ANALYZER ((B)(4)) COMPARED TO TWO COBAS 6000 C (501) MODULES. OF THE DATA PROVIDED, THERE WERE DISCREPANT SODIUM RESULTS FOR 2 PATIENT SAMPLES. PATIENT 1 ISE 9180 SODIUM RESULTS WERE 156 MMOL/L WITH A REPEAT RESULT OF 157 MMOL/L. THE SODIUM RESULTS FROM ONE C501 WERE 166 MMOL/L WITH A REPEAT RESULT OF 163 MMOL/L. THE SODIUM RESULTS FROM THE OTHER C501 WERE 161 MMOL/L WITH A REPEAT RESULT OF 161 MMOL/L. PATIENT 2 ISE 9180 SODIUM RESULTS WERE 143 MMOL/L WITH A REPEAT RESULT OF 143 MMOL/L. THE SODIUM RESULTS FROM ONE C501 WERE 149 MMOL/L WITH A REPEAT RESULT OF 145 MMOL/L. THE SODIUM RESULTS FROM THE OTHER C501 WERE 146 MMOL/L WITH A REPEAT RESULT OF 146 MMOL/L. THE ERRONEOUS RESULTS FROM THE (B)(4) WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FROM THE COBAS C501 ANALYZER WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE FIELD ENGINEERING SPECIALIST TESTED BOTH THE ISE HIGH AND THE ISE LOW CALIBRATORS ON THE TWO COBAS C501S COMPARED TO THE (B)(64. THE COBAS C501 RESULTS WERE HIGHER THAT THE (B)(4). THE REFERENCE ELECTRODE WAS EXCHANGED WITHOUT ANY IMPROVEMENT TO THE SITUATION. THE INVESTIGATION IS CURRENTLY ONGOING.