ELECSYS FT4 III ASSAY

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THAT THEY RECEIVED ERRONEOUS RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS FT3 III AND THE ELECSYS FT4 III ASSAY ON A COBAS 8000 E 801 MODULE. THE FT4 RESULT DID NOT FIT THE CLINICAL PICTURE OF THE PATIENT. THE ERRONEOUS VALUE WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE FT4 ASSAY. PLEASE REFER TO THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE FT3 ASSAY. THE PATIENT SAMPLE INITIALLY RESULTED WITH A FT3 VALUE OF 4.53 WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS REPEATED ON A BECKMAN ANALYZER, RESULTING WITH A FT3 VALUE OF 3.47 NG/L (REFERENCE RANGE = 3.40 - 6.30 NG/L). THE PATIENT SAMPLE INITIALLY RESULTED WITH A FT4 VALUE OF 25.3 NG/L WHEN TESTED ON THE E 801 ANALYZER. WHEN REPEATED ON THE BECKMAN ANALYZER, THE FT4 VALUE OF 14.6 NG/L (REFERENCE RANGE = 9.0-18.8 NG/L). NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(4).

Additional Manufacturer Narrative

THE CUSTOMER SENT THE PATIENT SAMPLE TO THE MANUFACTURER FOR INVESTIGATION. THE CUSTOMER'S FT3 AND FT4 RESULTS WERE REPRODUCED. NO INTERFERENCE WAS DETECTED. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.