ELECSYS T4 ASSAY

Additional Manufacturer Narrative

(B)(4). (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED OF QUESTIONABLE RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TSH ASSAY, ELECSYS T4 ASSAY (T4), ELECSYS T3 (T3), ELECSYS FT3 III (FT3 III), ELECSYS FT4 II ASSAY, ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO (ANTI-TPO), AND ROCHE DIAGNOSTICS ELECSYS ANTI-TG. THE PATIENT SAMPLES WERE TESTED ON TWO DIFFERENT COBAS 8000 E 602 MODULES AND COMPARED TO AN ABBOTT SYSTEM. "(B)(6)" COBAS E602 SERIAL NUMBER WAS (B)(4) AND "(B)(6)" COBAS E602 SERIAL NUMBER WAS (B)(4). OF THE DATA PROVIDED, THERE WERE REPORTABLE MALFUNCTIONS FOR T4, T3, FT3 III, AND ANTI-TPO. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE PATIENT HAS NO CLINICAL SYMPTOMS OF THYROID DISEASE. AN INTERFERING FACTOR IS BELIEVED TO PRESENT, BUT A PATIENT SAMPLE CAN NOT BE SHIPPED FOR FURTHER ANALYSIS DUE TO (B)(6) EXPORT CUSTOMS. MEDWATCHES FOR THIS EVENT INCLUDE THOSE WITH (B)(6). THE INVESTIGATION IS CURRENTLY ONGOING.

Additional Manufacturer Narrative

FURTHER ANALYSIS DETERMINED THAT A GENERAL REAGENT ISSUE IS CAN MOST LIKELY BE EXCLUDED. SINCE THE PATIENT SAMPLE CAN NOT BE MADE AVAILABLE FOR INTERFERENCE TESTING, THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.