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

Catalog Number	07027150190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); High Readings (2459); Low Readings (2460); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys cortisol ii results for 4 patient samples on a cobas e 801 module.On (b)(6) 2025, the customer performed qc and observed low results, which promoted them to repeat patient samples previously run from 03-jul to (b)(6) 2025.For patient 1, the initial cortisol result was 7.20 nmol/l.The repeat result was 1.50 nmol/l.For patient 2, the initial cortisol result was 5.60 nmol/l.The repeat result was 1.50 nmol/l.For patient 3, the initial cortisol result was 17.00 nmol/l.The repeat result was 4.40 nmol/l.For patient 4, the initial cortisol result was 6.40 nmol/l.The repeat result was 1.50 nmol/l.The exact dates of initial testing of the patient samples and information on which results were deemed correct was requested but not provided.
Additional Manufacturer Narrative
The patient samples affected were saliva samples.It was clarified that the repeat results were believed to be correct.The calibration recovery data provided was acceptable.The alarm trace showed multiple sample quality alarms.The field service engineer (fse) inspected the analyzer and did not find any issues.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The root cause of the event could not be determined.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22664343
• Report Number: 1823260-2025-02346
• Device Sequence Number: 7626259
• Product Code: JFT
• UDI-Device Identifier: 04015630939985
• UDI-Public: 04015630939985
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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 Expiration Date: 09/30/2025
• Device Catalogue Number: 07027150190
• Device Lot Number: 822771
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown