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

Catalog Number	06687733160
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys cortisol ii on a cobas e411 disk analyzer.The sample initially resulted in a cortisol value of 7.93 ug/dl.The doctor questioned the result and the sample was repeated, resulting in a value of 1.51 ug/dl.The repeat value was deemed correct and was expected for the patient.The customer re-centrifuged the sample and located a small clot in it.The clot was removed and the sample was repeated three additional times, resulting in cortisol values of 1.53 ug/dl, 2.25 ug/dl, and 2.39 ug/dl.
Additional Manufacturer Narrative
The serial number of the e411 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The customer verbally stated that the calibration and controls were acceptable.The sample centrifugation time was shorter and the speed was faster than recommended by the tube manufacturer.The field service engineer determined the issue was caused by a clot in the sample.Performance testing was run on the analyzer and was successful.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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17604100
• Report Number: 1823260-2023-02747
• Device Sequence Number: 6125940
• Product Code: JFT
• UDI-Device Identifier: 04015630940677
• UDI-Public: 04015630940677
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 09/01/2023

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: 06687733160
• Device Lot Number: ASKU
• 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: 07/27/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/01/2023
• 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 Age: 67 YR
• Patient Sex: Female