T4

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

(B)(4).

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR FREE THYROXINE (FT4). OF THE DATA PROVIDED, ERRONEOUS THYROTROPIN (TSH), FREE TRIIODOTHYRONINE (FT3), THYROXINE (T4), AND TRIIODOTHYRONINE (T3) WERE ALSO IDENTIFIED. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER T4. REFER TO MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT4 ERRONEOUS RESULTS, MEDWATCH WITH (B)(6) FOR INFORMATION ON THE TSH ERRONEOUS RESULTS, MEDWATCH WITH (B)(6) FOR INFORMATION ON THE FT3 ERRONEOUS RESULTS, AND MEDWATCH WITH (B)(6) FOR INFORMATION ON THE T3 ERRONEOUS RESULTS. BASED ON THE FT4 RESULTS, IT WAS SUSPECTED THAT THE PATIENT HAD HYPERTHYROIDISM AND WAS PRESCRIBED ANTI-THYROID MEDICATIONS OF PROPYLTHIOURACIL AND THIAMAZOLE FOR 2 CONSECUTIVE DAYS. NO ADVERSE EVENT OCCURRED DUE TO THIS TREATMENT. THE E601 ANALYZER USED AT THE CUSTOMER SITE WAS (B)(4).