ACCESS® THYROGLOBULIN

Additional Manufacturer Narrative

THERE IS NO INDICATION THE ACCESS THYROGLOBULIN DEVICE WAS RETURNED FOR EVALUATION. TESTING AT BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY CONFIRMED THE PRESENCE OF INTERFERING SUBSTANCES IN THE PATIENT'S SAMPLE. IN CONCLUSION, PATIENT SAMPLE INTERFERENCE IS THE ROOT CAUSE OF THE FALSELY ELEVATED THYROGLOBULIN (TG) RESULTS. PER PRODUCT LABELING: FOR ASSAYS EMPLOYING ANTIBODIES, THE POSSIBILITY EXISTS FOR INTERFERENCE BY HETEROPHILE ANTIBODIES IN THE PATIENT SAMPLE. PATIENTS WHO HAVE BEEN REGULARLY EXPOSED TO ANIMALS OR HAVE RECEIVED IMMUNOTHERAPY OR DIAGNOSTIC PROCEDURES UTILIZING IMMUNOGLOBULINS OR IMMUNOGLOBULIN FRAGMENTS MAY PRODUCE ANTIBODIES, E.G. HUMAN ANTI-MOUSE ANTIBODIES (HAMA), THAT INTERFERE WITH IMMUNOASSAYS. ADDITIONALLY, OTHER HETEROPHILE ANTIBODIES SUCH AS HUMAN ANTI-GOAT ANTIBODIES MAY BE PRESENT IN PATIENT SAMPLES. SUCH INTERFERING ANTIBODIES MAY CAUSE ERRONEOUS RESULTS. CAREFULLY EVALUATE THE RESULTS OF PATIENTS SUSPECTED OF HAVING THESE ANTIBODIES.

Description of Event or Problem

THE AFFILIATE STATED THE CUSTOMER REPORTED REPRODUCIBLE AND ELEVATED THYROGLOBULIN (TG) RESULTS, FOR ONE PATIENT, INVOLVING THE ACCESS THYROGLOBULIN ASSAY USED IN CONJUNCTION WITH THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE PATIENT WAS TESTED FOUR TIMES FOR TG ON THE SAME UNICEL DXI 800 SYSTEM. ALL RESULTS WERE COMPRISED BETWEEN 2 AND 3 NG/ML AND WERE DISCORDANT WITH TWO ALTERNATE METHODOLOGIES. THE ELEVATED RESULTS WERE RELEASED OUT OF THE LABORATORY. THE CUSTOMER STATED DUE TO THE HIGH RISK OF RELAPSE, THE PATIENT RECEIVED A SECOND DOSE OF IODINE-131 BASED ON THE ELEVATED RESULTS. IT IS UNKNOWN IF ANY ADDITIONAL TREATMENT WAS GIVEN TO THE PATIENT. THERE HAS BEEN NO REPORT OF CURRENT PATIENT OUTCOME. THE PATIENT¿S SAMPLES WERE SENT TO BECKMAN COULTER CUSTOMER PRODUCT LINE SUPPORT (CPLS) LABORATORY FOR FURTHER ANALYSIS.

Additional Manufacturer Narrative

(B)(4).