CORTISOL

Additional Manufacturer Narrative

(B)(4) THE EVENT OCCURRED IN: (B)(6).

Description of Event or Problem

THE CUSTOMER COMPLAINED THAT THE RESULTS FOR 1 PATIENT TESTED FOR ELECSYS CORTISOL TEST SYSTEM AND ELECSYS ACTH TEST SYSTEM (ACTH) ON A COBAS 8000 E 602 MODULE DO NOT MATCH THE CLINICAL PICTURE FOR THE PATIENT. IT IS NOT KNOWN IF THE INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL COVER CORTISOL. (B)(4). THE PATIENT WAS AT THE HOSPITAL AS THEY WERE DIAGNOSED WITH TERMINAL CHRONIC RENAL INSUFFICIENCY AND UNDERGOING DIALYSIS. A HORMONAL ASSESSMENT WAS ORDERED ON (B)(6) 2010 TO EXPLORE THE CORTICOTROPIC AXIS. ACTH WAS FOUND TO BE WEAK WHILE CORTISOL WAS HIGH WHICH WAS INCONSISTENT WITH THE CLINICAL STATUS. SPECIFIC RESULTS WERE NOT PROVIDED. THE PATIENT WAS THEN QUESTIONED AND A BIOTIN INTAKE WAS FOUND. ACTH AND CORTISOL TESTING WAS THEN PERFORMED WITH A DIFFERENT ASSAY TECHNIQUE. SPECIFIC METHOD USED AND SPECIFIC RESULTS WERE NOT PROVIDED. THE PATIENT HAD BIOTIN TESTING PERFORMED AND THE TESTING CONFIRMED A HIGH CONCENTRATION OF BIOTIN IN THE BODY. THE BIOTIN RESULT WAS GREATER THAN 160 NMOL/L. NO INFORMATION IS KNOWN ABOUT THE CURRENT STATUS OF THE PATIENT. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE COBAS E602 SERIAL NUMBER WAS NOT PROVIDED.

Additional Manufacturer Narrative

SINCE THERE IS NO SAMPLE AVAILABLE TO INVESTIGATE AND DUE TO A GENERAL LACK OF INFORMATION AVAILABLE, FURTHER INVESTIGATION INTO THE CLAIM OF A POSSIBLE BIOTIN INTERFERENCE IS NOT POSSIBLE. PRODUCT LABELING FOR ACTH INDICATES THE ASSAY IS UNAFFECTED BY BIOTIN LEVELS UP TO 246 NMOL/L. PRODUCT LABELING FOR CORTISOL INDICATES THE ASSAY IS UNAFFECTED BY BIOTIN LEVELS UP TO 123 NMOL/L. FOR BOTH ACTH AND CORTISOL TESTING, SAMPLES SHOULD NOT BE TAKEN FROM PATIENTS RECEIVING THERAPY WITH HIGH BIOTIN DOSES (I.E. > 5 MG/DAY) UNTIL AT LEAST 8 HOURS FOLLOWING THE LAST BIOTIN ADMINISTRATION. FROM THE INFORMATION PROVIDED A GENERAL REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED.