MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CORTISOL II; FLUOROMETRIC, CORTISOL

Model Number	CORTISOL G2
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys cortisol ii on a cobas 8000 e 801 module (serial number 1795-01).No incorrect results were reported outside of the laboratory.The sample initially resulted in a cortisol value of 1636 nmol/l when tested on the e 801 analyzer.The sample was repeated on the e 801 analyzer and the result was the same.The sample was tested using a liquid chromatography coupled mass spectroscopy (lcms) method, resulting in a value of 849.4 nmol/l.
Additional Manufacturer Narrative
Based on the available information, the patient was taking metyrapon.Per product labeling: "during metyrapon tests, 11-deoxycortisol levels are elevated.Falsely elevated cortisol values may be determined due to cross reactions." the most likely causal factor for the high elecsys cortisol ii result in comparison to lc-ms is cross reactions, which are at least partly due to 11-deoxycortisol.Based on the provided patient history (carcinoma + further medications spironolactone, prednisone) and considering potential metabolic and pharmacodynamic effects, cross reactions to other components cannot be entirely excluded.The investigation could not identify a product problem.

• Brand Name: ELECSYS CORTISOL II
• Common Device Name: FLUOROMETRIC, CORTISOL
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14516116
• Report Number: 1823260-2022-01495
• Device Sequence Number: 12420929
• Product Code: JFT
• UDI-Device Identifier: 04015630939985
• UDI-Public: 04015630939985
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K152227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CORTISOL G2
• Device Catalogue Number: 07027150190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 06/28/2022
• Initial Report FDA Received Date: 05/26/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 11-DEOXYCORTISOL; ALDACTONE (SPIRONOLACTONE); MEPTYRAPONE; PREDNISONE
• Patient Age: 69 YR
• Patient Sex: Female