ELECSYS FT3 III

Additional Manufacturer Narrative

THE COBAS E601 ANALYZER WAS WITH A SERIAL NUMBER OF (B)(6). QC WAS LAST PERFORMED ON 24-MAY-2023. THE ANALYZER HAD REAGENT ERRORS ON THE DAY OF THE EVENT AND THE QC COULDN'T BE PERFORMED. THE PROVIDED ALARM TRACE CONTAINED SEVERAL ALARMS INCLUDING SAMPLE SHORT ALARMS. THE FIELD SERVICE ENGINEER (FSE) FOUND THAT SALT WAS BUILT UP ON THE NOZZLE AND THE ASSEMBLY WHICH WERE CLEANED AND RESEATED. THE CUSTOMER PERFORMED CALIBRATION AND QC AND THEY WERE ACCEPTABLE. THE CUSTOMER THEN RAN A PATIENT SAMPLE AND THE RESULT MATCHED THE RESULT FROM THE OTHER ANALYZER. THE INVESTIGATION DETERMINED THAT THE FSE SERVICE ACTIONS SOLVED THE ISSUE. H3 OTHER TEXT : NA

Description of Event or Problem

WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S PLASMA SAMPLE TESTED WITH ELECSYS FT3 G3 (FT3 III) ASSAY ON A COBAS E601 IMMUNOASSAY ANALYZER WHEN COMPARED TO ANOTHER COBAS E601 IMMUNOASSAY ANALYZER. THE CUSTOMER REPORTED A >25 PG/ML WHICH WAS ACCOMPANIED BY A DATA FLAG >TEST. THE CUSTOMER DID NOT REALIZE THAT THE INSTRUMENT NEEDED TO DILUTE THE SAMPLE AND THE DILUTED VALUE WAS 7.5 PG/ML . THE REPEAT RESULT WAS 2.5 PG/ML (ON A DIFFERENT E601) WHICH WAS DEEMED CORRECT. THE LABORATORY IS IN THE PROCESS OF CORRECTING THE REPORT.