T4

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER REPORTED DISCORDANT RESULTS FOR THYROID TESTS. ONE PATIENT SAMPLE WAS TESTED FOR THYROTROPIN(TSH), THYROXINE (T4), FREE THYROXINE (FT4), TRIIODOTHYRONINE (T3), AND FREE TRIIODOTHYRONINE (FT3). THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER T4. REFER TO THE ATTACHED DATA FOR THE PATIENT RESULTS. REFER TO MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TSH ERRONEOUS RESULTS, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE FT4 ERRONEOUS RESULTS, MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ERRONEOUS T3 RESULTS AND MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE INFORMATION ON THE ERRONEOUS FT3 RESULTS. THE SAMPLE WAS INITIALLY TESTED ON THE E602 ANALYZER AND THEN REPEATED ON AN ABBOTT ARCHITECT ANALYZER. BASED ON THE CLINICAL STATUS OF THE PATIENT, THEY EXPECTED RESULTS IN THE NORMAL RANGE FOR SOMEONE WITH A NORMAL FUNCTIONING THYROID. THE ORIGINAL SAMPLE WAS THEN TREATED WITH HBT SCANTIBODIES TUBES AND TESTS WERE RE-RUN ON THE E602 ANALYZER AND REPEATED ON THE ABBOTT ARCHITECT ANALYZER. NO ADVERSE EVENTS WERE REPORTED. THE FT4 REAGENT LOT NUMBER WAS 180539. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE FT3 REAGENT LOT NUMBER WAS 180230. THE EXPIRATION DATE WAS REQUESTED BUT NOT PROVIDED. THE LOT NUMBERS AND EXPIRATION DATES FOR TSH, T3 AND T4 WERE REQUESTED BUT NOT PROVIDED. THE COBAS E602 ANALYZER SERIAL NUMBER WAS (B)(4).

Additional Manufacturer Narrative

THE SAMPLE WAS SUBMITTED FOR INVESTIGATION. INVESTIGATION CONFIRMED THE PRESENCE OF A STREPTAVIDIN INTERFERING FACTOR. THIS SPECIFIC INTERFERENCE IS ADDRESSED IN PRODUCT LABELING.

Additional Manufacturer Narrative

LOT NUMBER WAS UPDATED.