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

Model Number	DHEA-S
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned results for 1 patient sample tested for elecsys dhea-s (dhea-s) on a cobas e 402 analytical unit.The initial result was > 1000 g/dl with a data flag.The repeat using a 1:5 dilution was 113 g/dl; the calculated result was 565 g/dl.The measuring range of the assay is 0.2 ¿ 1000 g/dl.The customer questions why the sample would require dilution, as the result of 565 g/dl was within the measuring range of the assay.The customer suspects an interference.
Additional Manufacturer Narrative
Calibration and qc were acceptable.The alarm trace was reviewed, and no alarms related to the event were identified.The sample was requested for investigation, but could not be provided.The customer declined to provide any additional patient information.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 23865711
• Report Number: 1823260-2025-05277
• Device Sequence Number: 17478816
• Product Code: JKC
• UDI-Device Identifier: 04015630940387
• UDI-Public: 04015630940387
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• 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): 01/30/2026

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: 857267
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/30/2026
• 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