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

Catalog Number	06687733160
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	04/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 6000 e 601 module is (b)(6).The field service engineer (fse) inspected the module and cleaned and adjusted the tubing of the extra wash station (ews).The customer performed calibration and qc with acceptable results.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable elecsys cortisol ii and elecsys acth test system (acth) result from one patient sample tested on the cobas 6000 e601 module.This medwatch is for the elecsys cortisol ii assay.Please refer to the medwatch with a1.Patient identifier (b)(6) for the elecsys acth test system (acth) assay report.The initial result of the initial patient sample was 24.27 ug/dl (24.3 ug/dl).The repeat result of the initial patient sample was 23.73 ug/dl.The result of a new patient sample was 12.51 ug/dl (12.5 ug/dl).The physician questioned the initial result as it did not match the patient's previous result, prompting the patient's sample to be rerun.The result of the new patient sample was deemed correct.
Additional Manufacturer Narrative
The calibration results were acceptable.The qc results were within the specified ranges.The alarm trace did not indicate any issues.The patient sample was centrifuged for five minutes.A general reagent or analyzer problem was not detected because the qc before the event was within range; isolated non-reproducible results do not represent a general malfunction of the assay.The event's cause could not be determined based on the information provided.The investigation did not identify a product problem.

• 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: 21892558
• Report Number: 1823260-2025-01247
• Device Sequence Number: 18190233
• Product Code: JFT
• UDI-Device Identifier: 04015630940677
• UDI-Public: 04015630940677
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 04/30/2025
• Device Catalogue Number: 06687733160
• Device Lot Number: 78685200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/09/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LONG TERM CURRENT DRUG THERAPY: CHEMOTHERAPY
• Patient Age: 52 YR
• Patient Sex: Female