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

Model Number	TESTOSTERONE
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys testosterone ii assay on a cobas e 801 analytical unit.The sample initially resulted in a testosterone value of 46 nmol/l.The sample was repeated on (b)(6) 2026, resulting in a value of 40.5 nmol/l.The sample was tested on a competitor system (abbott alinity) and it resulted in a testosterone value of 10.3 nmol/l.The sample was also tested using the lc-ms/ms method, resulting in a testosterone value of 12.3 nmol/l.
Additional Manufacturer Narrative
The e 801 analyzer serial number is (b)(6).The patient's sample was requested for investigation.The investigation is ongoing.

• 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: 24616337
• Report Number: 1823260-2026-00942
• Device Sequence Number: 13155521
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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: 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: 02/24/2026
• Supplement Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 06/01/2026
• 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