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

Catalog Number	07027150190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s e801 analyzer serial number was (b)(6).The serial number for the e801 module used at the investigation site was not provided.
Event or Problem Description
The initial reporter questioned high results not corresponding to the clinical picture for 1 patient sample tested for elecsys acth (acth) and elecsys cortisol ii (cortisol ii) compared to other samples from the patient on a cobas e 801 analytical unit.This medwatch will cover cortisol ii.Refer to medwatch with a1 patient identifier pt-(b)(6) for information on the acth results.On 03-sep-2024 the acth result was 3 pg/ml and the cortisol ii result was 7 ug/dl.On 10-sep-2024 the acth result was 270 pg/ml.The repeat on 11-sep-2024 was 130 pg/ml.On 10-sep-2024 the cortisol ii result was 105 ug/dl.On 11-sep-2024 the acth result was 6 pg/ml and the cortisol ii result was 6 ug/dl.The sample from 10-sep-2024 was submitted for investigation and tested on an e801 module.The acth result was 101 pg/ml.The cortisol ii result was 111 ug/dl.
Additional Manufacturer Narrative
The customer did not provide any additional information for the investigation.The sample from (b)(6) 2024 was tested at the investigation site on (b)(6) 2024.Product labeling states: "only use pre-cooled sampling vials.After drawing the blood, put the vials immediately on ice.Use a cooled centrifuge to separate the plasma.Measure samples immediately or freeze them at -20 °c.Stable for 3 hours at 2-8 °c followed by 2 hours at 20-25 °c." the sample was stored unfrozen for too long.And "acth concentrations vary considerably depending on physiological conditions.Therefore, acth results should always be evaluated together with simultaneously measured cortisol concentrations." it was noted that the patient had "a tendency for depression" and the high acth and cortisol results were "due to a combination of factors." 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: 20473593
• Report Number: 1823260-2024-03008
• Device Sequence Number: 15356780
• 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
• Report Date (Section B): 11/21/2024

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: 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: 09/26/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 10/17/2024
• Supplement Report FDA Received Date: 11/21/2024
• 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