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

Catalog Number	07027150190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable elecsys cortisol ii results from two patient samples (saliva) tested on the cobas e 801 module.The initial results were not reported outside of the laboratory as they were considered incorrect.Patient 1: on (b)(6) 2023, the initial result was 322 nmol/l.On (b)(6) 2023, the repeat result was 2 nmol/l.Patient 2: on (b)(6) 2023, the initial result was 373 nmol/l.The repeat result was 5.2 nmol/l.The repeat results were deemed correct.
Additional Manufacturer Narrative
The serial number of the customer's cobas e 801 module is 18g2-08.The alarm trace from (b)(6) 2023 showed multiple messages potentially related to sample quality ("sample foam detection"; "sample clot detection"; and "sample short" alarms).The field service engineer (fse) inspected the module and noted that the nozzles had dirty tips and showed high wear.He replaced the nozzles and changed all positioning settings.He checked all of the probes and sippers in their washes and found them to be in good condition and correct positions.He also checked and cleaned the entire reading line in one of the cells.He performed an instrument check with successful results.The investigation is ongoing.
Additional Manufacturer Narrative
After service, no further issues were reported by the customer.The investigation did not identify a product problem.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17816623
• Report Number: 1823260-2023-03100
• Device Sequence Number: 16754081
• Product Code: JFT
• UDI-Device Identifier: 04015630939985
• UDI-Public: 04015630939985
• Combination Product (Y/N): Y
• 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): 10/17/2023

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 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: 09/01/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/26/2023
• Supplement Report FDA Received Date: 10/17/2023
• 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
• Patient Sex: Unknown