MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS DHEA-S; DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM

Catalog Number	03000087122
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable elecsys dhea-s result from the cobas e 602 module.The initial result was > 1000 g/dl, and the repeat result was > 1000 g/dl.The sample was repeated on a non-roche device with a result of 301.07 g/dl.The sample was repeated on another non-roche device with a result of 212.502 g/dl.The initial result was questioned because it did not match the patient's clinical diagnosis and was not released outside of the laboratory.The results of 301.07 g/dl and 212.502 g/dl are deemed to be correct.
Additional Manufacturer Narrative
The cobas e 602 module (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
The patient stopped taking the maca (lepidium meyenii) medication for a month.The elecsys dhea-s result was still >1000 ug/dl.The calibration and qcs were acceptable.The patient sample was received for investigation and was tested for interferents.The investigation detected the presence of an interferent in the patient sample, which caused the event.Product labeling states, "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 (FREE AND SULFATE) 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: 22131214
• Report Number: 1823260-2025-01701
• Device Sequence Number: 20925677
• Product Code: JKC
• UDI-Device Identifier: 04015630917372
• UDI-Public: 04015630917372
• 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): 09/08/2025

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: 10/31/2025
• Device Catalogue Number: 03000087122
• Device Lot Number: 79098700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MACA - LEPIDIUM MEYENII.
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Race: Asian