ROCHE 9180 ELECTROLYTE ANALYZER

Additional Manufacturer Narrative

SECTION D PRODUCT INFORMATION HAS BEEN UPDATED, AS WELL AS G1 MANUFACTURING SITE AND G4. THE CALIBRATION AND QC RECOVERY DATA WAS WITHIN SPECIFICATION. THE FIELD SERVICE ENGINEER (FSE) CLEANED THE ANALYZER, CONDITIONED THE MEMBRANES, FOUND A SNAPPAK LEAK AND REPLACED IT, AND PERFORMED QC SUCCESSFULLY. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.

Additional Manufacturer Narrative

THE ANALYZER SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE ROCHE 9180 POTASSIUM ELECTRODE RESULTS FOR 1 PATIENT SAMPLE ON A ROCHE 9180 ELECTROLYTE ANALYZER. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLE AS THE INITIAL RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE INITIAL RESULT WAS 5.2 MMOL/L. THE REPEAT RESULT WAS 4.4 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.