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

Model Number	DHEA-S
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys dhea-s assay result for a patient sample tested on a cobas e 801 analytical unit.The initial result was >1000 g/dl.The repeat result was >1000 g/dl.The sample was diluted 1:2, and the result was 1028 g/dl.The sample was diluted 1:4, and the result was 973 g/dl.The sample was repeated on the abbott test, and the result was 479.9 g/dl.The patient¿s concurrent lc-ms (mass spectrometry) result was 3.14 g/ml.No erroneous results were released.The test was repeated as the result did not match the patient's clinical diagnosis.The customer suspects interference.
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The sample material was requested for investigation.
Additional Manufacturer Narrative
Investigation of the sample material confirmed a streptavidin interference in the sample, causing the elevated elecsys results compared to the competitor and lc-ms.This is a known interference clearly disclaimed in the method sheet, "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.

• 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: 24199418
• Report Number: 1823260-2026-00303
• Device Sequence Number: 5430958
• Product Code: JKC
• UDI-Device Identifier: 04015630940387
• UDI-Public: 04015630940387
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/05/2026

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 Model Number: DHEA-S
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/05/2026
• 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