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

Catalog Number	07027150190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial numbers of the unknown roche analyzer used at the customer site and the e801 module used for investigation were requested, but not provided.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for four patient samples tested with elecsys cortisol ii on an unknown roche elecsys analyzer.The fourth patient sample also had discrepant results when tested on a cobas e801 module used for investigation.The results did not agree with results obtained with a competitor method (siemens).The first sample resulted in a cortisol value of 4.57 ug/l when tested with the roche assay.When tested with the siemens assay, the sample resulted in a cortisol value of 28.1 ug/dl.The second sample resulted in a cortisol value of 3.82 ug/l when tested with the roche assay.When tested with the siemens assay, the sample resulted in a cortisol value of 9.0 ug/dl.The third sample resulted in a cortisol value of 2.59 ug/l when tested with the roche assay.When tested with the siemens assay, the sample resulted in a cortisol value of 11.3 ug/dl.An aliquot of the fourth sample (tube a) resulted in a cortisol value of 2.39 ug/dl when tested with the roche assay on (b)(6) 2023.A second aliquot of the same sample (tube b) was tested with the siemens assay on (b)(6) 2023, resulting in a cortisol value of 16.3 ug/dl.The 2 aliquots of this sample were provided for investigation where they were tested on an e801 analyzer; tube a resulted in a cortisol value of 2.35 ug/dl and tube b resulted in a cortisol value of 2.09 ug/dl.
Additional Manufacturer Narrative
Samples 1 and 4 are from the same patient.
Additional Manufacturer Narrative
Quality controls recovered within range.There was no indication of a general reagent issue.Further investigations of the fourth sample were able to reproduce the roche assay values when tested with a second competitor method (archie) and lc-ms/ms.The investigation concluded the roche cortisol values of the samples were correct.The investigation did not identify a product issue.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17848209
• Report Number: 1823260-2023-03141
• Device Sequence Number: 20644860
• Product Code: JFT
• UDI-Device Identifier: 04015630939985
• UDI-Public: 04015630939985
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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): 12/13/2023

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 Catalogue Number: 07027150190
• Device Lot Number: 669218
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 09/29/2023; 12/07/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/23/2023; 12/13/2023
• 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