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

Model Number	CORTISOL G2
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with elecsys cortisol ii on a cobas 8000 e 801 module.No questionable results were reported outside of the laboratory.The reporter noted that controls were lower, but still acceptable.The samples were then initially tested.Later, the customer noted that controls recovered better in a standby cortisol reagent pack, so they decided to repeat the samples.The results were discrepant.The customer then changed the reagent pack that was initially used and there were no further issues.The first sample initially resulted in a cortisol value of 1.63 nmol/l.The sample was repeated on (b)(6) 2023, resulting in a value of 4.17 nmol/l.The second sample resulted in a cortisol value of 4.64 nmol/l.The sample was repeated on (b)(6) 2023, resulting in a value of 6.71 nmol/l.The serial number of the e 801 analyzer is (b)(4).
Additional Manufacturer Narrative
The last calibration performed on (b)(6)-2023 was within specifications.The provided calibration signals were slightly lower than expected but this does not appear to affect the performance of the calibration.The qc recovery was within the customer¿s established ranges.There was no indication of a performance issue with the reagent or instrument.Based on the information provided, the 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16280235
• Report Number: 1823260-2023-00302
• Device Sequence Number: 6973102
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2023

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: 63438801
• 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: 01/12/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/15/2023
• 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: 45 YR
• Patient Sex: Male