MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TESTOSTERONE II ASSAY; TESTOSTERONE ASSAY

Model Number	TESTOSTERONE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The patient sample was received for investigation, and it was confirmed that the sample contains an interferent to the streptavidin component of the reagent.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys testosterone ii assay and elecsys estradiol iii results for one patient sample on a cobas e 801 analytical unit.This medwatch will cover elecsys testosterone ii assay.Refer to medwatch with a1 patient identifier (b)(6) for information on the elecsys estradiol iii assay.The patient had been continuously monitored for over three months and had consistently elevated results from three e 801 analyzers.The patient went to another hospital for testing and reported to the clinician that the results from a siemens analyzer were normal.On (b)(6) 2025, the patient had new samples collected.The testosterone result from the analyzer was 3.39 nmol/l.The testosterone result from a mass spectrometry analyzer was 1.401 nmol/l.The estradiol result from the analyzer was 2444 pmol/l.The estradiol result from a mass spectrometry analyzer was 896 pmol/l.The mass spectrometry results were within the normal reference range.The reporter suspects an interferent in the patient's sample.
Additional Manufacturer Narrative
Per 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." no product problem was identified.

• Brand Name: ELECSYS TESTOSTERONE II ASSAY
• Common Device Name: TESTOSTERONE ASSAY
• 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: 23524601
• Report Number: 1823260-2025-04584
• Device Sequence Number: 10186817
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K211685
• 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): 12/03/2025

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: 09/30/2026
• Device Model Number: TESTOSTERONE
• Device Catalogue Number: 08946370190
• Device Lot Number: 872064
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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: Female