AMMONIA II

Additional Manufacturer Narrative

THE FIELD SERVICE ENGINEER DETERMINED THERE WAS AN ISSUE WITH THE AMMONIA REAGENT CASSETTE. HE REPLACED THE GEAR PUMP AS THE GAUGE WAS NOT WORKING, AND REPLACED THE RINSE TUBING. HE RAN PRECISION TESTING. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

Additional Manufacturer Narrative

THE COBAS 6000 C 501 SERIAL NUMBER WAS (B)(6). THE CUSTOMER LOADED A NEW REAGENT PACK OF A DIFFERENT LOT (83242101) THAT WAS FROM A DIFFERENT SHIPMENT. THE CUSTOMER REPEATED PREVIOUSLY TESTED PROFICIENCY SAMPLES AND THE RESULTS WERE MUCH LOWER. FOR TROUBLESHOOTING PURPOSES, THE CUSTOMER ALSO TESTED SAMPLES DRAWN FROM EMPLOYEES ON BOTH REAGENT PACKS AND THE RESULTS WERE MUCH LOWER WITH THE NEW REAGENT PACK. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH AMMONIA II RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE DOCTOR QUESTIONED THE HIGH RESULT AS IT DID NOT MATCH THE CLINICAL PICTURE. THE INITIAL RESULT WAS 383 MOL/L. THE CUSTOMER REPEATED THE SAME AND THE RESULT WAS STILL HIGH. NO SPECIFIC DATA WAS PROVIDED. THE RESULT FROM A NEW SAMPLE FROM THE PATIENT TESTED AT ANOTHER LABORATORY WAS <10 MOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT.