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

Catalog Number	07027192190
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	10/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).Sample material was requested for investigation.
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient tested for elecsys dhea-s (dhea-s) on a cobas e 801 analytical unit compared to the liquid chromatography-mass spectrometry (lc-ms) method.The initial result was >1000 ug/dl.The sample was repeated "several" times and the results remained >1000 ug/dl.The high results were not reported outside of the laboratory.Due to the high results, repeat testing by lc-ms was requested.The result from the lc-ms method was 382.54 ug/dl.This result was believed to be correct.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Sample material was received for investigation.Further investigation of the patient sample suggests the presence of an interferent against the streptavidin component of the reagent.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." 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20668217
• Report Number: 1823260-2024-03284
• Device Sequence Number: 8231350
• 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
• Report Date (Section B): 01/03/2025

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: 07027192190
• Device Lot Number: 79099701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 11/12/2024
• Supplement Report FDA Received Date: 01/03/2025
• 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