ELECSYS FT3 III

Additional Manufacturer Narrative

QUALITY CONTROL DATA WAS ACCEPTABLE. SINCE THE ELEVATED TSH AND LOW FT3 RESULTS WERE CONFIRMED WITH THE SIEMENS METHOD, AN INTERFERENCE WITH THE ELECSYS ASSAY CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE. A REAGENT ISSUE CAN BE EXCLUDED.

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS TSH ON A COBAS E 801 ANALYTICAL UNIT. THE TSH RESULTS WERE CONSIDERED TOO HIGH AND THE CUSTOMER SUSPECTS THE SAMPLE CONTAINS AN INTERFERING FACTOR AGAINST A COMPONENT OF THE TSH ASSAY. THE SAMPLE ALSO HAD DISCREPANT RESULTS FOR ELECSYS FT3 III WHEN COMPARED TO THE FT3 VALUE MEASURED ON A COMPETITOR SYSTEM (SIEMENS). THIS MEDWATCH WILL APPLY TO THE FT3 ASSY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE TSH ASSAY. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS TESTED AT THE CUSTOMER SITE ON 15-SEP-2023. THE SAMPLE WAS REPEATED FOR TSH ON THE E801 ANALYZER AFTER A X10 AUTOMATIC DILUTION. TSH WAS ALSO RE-MEASURED ON THE E801 ANALYZER AFTER BEING DILUTED X2 AND TREATED WITH POLYETHYLENE GLYCOL (PEG). THE SAMPLE WAS REPEATED FOR TSH AND FT3 ON A SIEMENS ANALYZER.

Additional Manufacturer Narrative

THE SERIAL NUMBER OF THE CUSTOMER'S E801 ANALYZER IS (B)(6). MEDWATCH FIELD E1. FACILITY NAME - (B)(6). THE INVESTIGATION IS ONGOING.