MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS DHEA-S; DEHYDROEPIANDROSTERONE TEST SYSTEM

Catalog Number	07027192190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned high results for 1 patient tested for elecsys dhea-s (dhea-s) on a cobas 8000 e 801 module.The result from the e801 module was > 1000 ug/dl.The sample was repeated "several" times and the results were reproduced.The sample was tested by liquid chromatography-mass spectrometry (lc-ms) and the result was 93.27 ug/dl.The customer suspects an interference affecting the roche results.
Additional Manufacturer Narrative
The e801 module serial number was (b)(6).Sample material was requested for investigation.
Additional Manufacturer Narrative
Calibration and qc were acceptable.One sample short alarm was observed within the alarm trace data on (b)(6) 2025.No instrument maintenance issues were identified.The sample was submitted for investigation.The customer's dhea-s results were reproduced.Upon further investigation of the patient sample, an interferent against the streptavidin component of the reagent was confirmed.This interference is covered in product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." the investigation did not identify a product problem.
Additional Manufacturer Narrative
The liquid chromatography-mass spectrometry (lc-ms) result was believed to be correct.

• Brand Name: ELECSYS DHEA-S
• Common Device Name: DEHYDROEPIANDROSTERONE TEST SYSTEM
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22505971
• Report Number: 1823260-2025-02140
• Device Sequence Number: 9303838
• Product Code: JKC
• UDI-Device Identifier: 04015630940387
• UDI-Public: 04015630940387
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K003174
• 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): 09/29/2025

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: 08/31/2026
• Device Catalogue Number: 07027192190
• Device Lot Number: 85726701
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 09/18/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/06/2025; 09/29/2025
• 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
• Patient Sex: Unknown