ELECSYS CORTISOL TEST SYSTEM

Additional Manufacturer Narrative

THE CUSTOMER CALIBRATION SIGNALS RECOVERED SLIGHTLY LOWER THAN THE ACCEPTABLE RANGES. THE CUSTOMER QC RECOVERY WAS ACCEPTABLE. THE OBSERVED DIFFERENCES IN THE ELECSYS CORTISOL TEST SYSTEM VALUES GENERATED WITH THE ROCHE ASSAY AND LC-MS METHOD ARE MOST LIKELY CAUSED BY DIFFERENCES IN THE OVERALL SETUPS OF THE ASSAYS, THE ANTIBODIES USED, DIFFERENCES IN REFERENCE MATERIALS, AND THE DIFFERENCES IN THE STANDARDIZATION METHODOLOGY USED. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE CAN BE EXCLUDED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

Additional Manufacturer Narrative

THIS EVENT OCCURRED IN (B)(6).

Description of Event or Problem

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR THREE PATIENT SAMPLES TESTED WITH THE ELECSYS CORTISOL TEST SYSTEM ON A COBAS E 411 IMMUNOASSAY ANALYZER. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED WITH A CORTISOL VALUE OF 2.22 UG/L WHEN TESTED ON THE E 411 ANALYZER. WHEN REPEATED USING THE LC-MS METHOD, THE SAMPLE RESULTED WITH A VALUE OF 5.68 UG/L. THE SECOND SAMPLE INITIALLY RESULTED WITH A CORTISOL VALUE OF 2.79 UG/L WHEN TESTED ON THE E 411 ANALYZER. WHEN REPEATED USING THE LC-MS METHOD, THE SAMPLE RESULTED WITH A VALUE OF 6.15 UG/L. THE THIRD SAMPLE INITIALLY RESULTED WITH A CORTISOL VALUE OF 2.56 UG/L WHEN TESTED ON THE E 411 ANALYZER. WHEN REPEATED USING THE LC-MS METHOD, THE SAMPLE RESULTED WITH A VALUE OF 5.76 UG/L. THE RESULTS FROM THE LC-MS METHOD WERE BELIEVED TO BE CORRECT. SAMPLES WERE NOT COLLECTED IN SALIVETTE SALIVA TUBES. THE E411 ANALYZER SERIAL NUMBER WAS (B)(4).