ELECSYS CORTISOL II

Description of Event or Problem

WE RECEIVED AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ELECSYS CORTISOL II (CORTISOL II). SPECIFIC HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE WERE PROVIDED FOR 1 PATIENT TESTED ON (B)(6) 2025, ON A COBAS E 411 ANALYZER (RACK SYSTEM). THE SERUM RESULTS WERE 28.64 UG/DL AND 28.67 UG/DL. THE PLASMA RESULTS WERE 27.98 UG/DL AND 27.28 UG/DL. THE RESULTS WERE FROM THE SAME SAMPLE DRAWN AT THE SAME TIME. REPORTEDLY, THE EXPECTED CORTISOL RESULT WAS 0 UG/DL. THE PATIENT HAD ALLEGEDLY PREVIOUSLY UNDERGONE A SUPPRESSION TEST, AND CORTISOL WAS HIGH; HOWEVER, THE PATHOLOGIST DID NOT FIND CORTISOL-SECRETING CELLS IN THE ADRENAL GLAND.

Additional Manufacturer Narrative

THE E411 ANALYZER SERIAL NUMBER WAS (B)(6). SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.

Additional Manufacturer Narrative

QC WAS ACCEPTABLE. LIQUID FLOW CLEANING (LFC) IS PERFORMED WEEKLY. SAMPLE MATERIAL WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS TESTED WITH THE ELECSYS CORTISOL II ASSAY ON A COBAS E 411 ANALYZER AND WITH THE IONIFY CORTISOL ASSAY ON A COBAS I 601 (MASS SPECTROMETRY). COBAS E411: 25.56 UG/DL. COBAS I601: 27.9 UG/DL. THE CORTISOL RESULTS FROM BOTH METHODS WERE COMPARABLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. ALL ELECSYS RESULTS ARE BELIEVED TO BE CORRECT.