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

Model Number	CORTISOL G2
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na h3 other text : na.
Event or Problem Description
The initial reporter stated they received questionable low results for an unspecified number of patient samples tested with elecsys cortisol ii on cobas e 801 analytical unit serial number (b)(6).Samples collected from these patients in the morning will have low cortisol values.When collecting samples from these patients in the afternoon, the results are higher and within the normal expected range of the assay.The customer provided an example of one patient sample that had a questionable result.The complained sample resulted in cortisol values of 4.52 ug/dl and 4.63 ug/dl.The 4.63 ug/dl value was reported outside of the laboratory to the endocrinologist.The value did not agree with the patient's history.A second sample collected from the same patient in the afternoon resulted in a cortisol value of 8.71 ug/dl.
Additional Manufacturer Narrative
Calibration data was within expectations.Quality control data provided from (b)(6) 2023 to (b)(6) 2023 were within specifications.Control data from the date of the event was not provided.Samples are kept uncentrifuged for 4 hours before they are centrifuged and analyzed.The tube manufacturer recommends a maximum time of 2 hours between collection and centrifugation.The investigation determined the issue is consistent with incorrect pre-analytic sample handling.

• 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: 16855050
• Report Number: 1823260-2023-01487
• Device Sequence Number: 15094175
• Product Code: JFT
• UDI-Device Identifier: 04015630939985
• UDI-Public: 04015630939985
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/17/2023

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: 11/30/2023
• Device Model Number: CORTISOL G2
• Device Catalogue Number: 07027150190
• Device Lot Number: 66921801
• 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: 04/19/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NO MEDICATIONS
• Patient Age: 20 YR
• Patient Sex: Female