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	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The samples were requested for investigation.
Event or Problem Description
The initial reporter stated they received questionable results for two samples from one patient tested with the elecsys cortisol ii assay on a cobas e 801 analytical unit (serial number).An interference is suspected as the cobas e 801 results did not agree with the clinical status of the patient.On (b)(6) 2023 a sample from the patient resulted in a cortisol ii value of 1174 mmol/l.On (b)(6) 2023 a sample from the patient resulted in a cortisol ii value of 1043 mmol/l.The samples were also tested with a competitor method, resulting in a cortisol value of 600 nmol/l.No specific date was provided.The questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
During investigations, the cortisol concentration in the alleged samples was further determined with a liquid chromatography with tandem mass spectrometry (lc-ms/ms) method and was found to be in agreement with the elecsys cortisol ii results.The investigation could not identify a product problem.The elecsys cortisol ii results are considered correct.
Additional Manufacturer Narrative
The patient samples were provided for investigation.The customer¿s cortisol ii results could be reproduced.No interfering factor against the streptavidin component of the reagent could be detected in the samples.The investigation is ongoing.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16684184
• Report Number: 1823260-2023-01104
• Device Sequence Number: 7967461
• Product Code: JFT
• UDI-Device Identifier: 04015630939985
• UDI-Public: 04015630939985
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 07/18/2023

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: 05/31/2023
• Device Model Number: CORTISOL G2
• Device Catalogue Number: 07027150190
• Device Lot Number: 634388
• 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: 03/09/2023
• Supplement Date Received by Manufacturer: 05/12/2023; 06/30/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/07/2023; 07/18/2023
• 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
• Patient Age: 34 YR
• Patient Sex: Female