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

Catalog Number	08946370190
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	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys testosterone g2 (testosterone ii) assay on a cobas e 801 analytical unit.The sample was tested on siemens, and the result was 897 ng/dl.The original sample was tested on an e801, and the result was 1500 ng/dl (accompanied by a data flag).On (b)(6) 2025, the original sample was repeated twice on e801, and the repeat results were both 1500 ng/dl (accompanied by data flags).On (b)(6) 2025, the original sample was repeated on siemens, and the repeat result was 897 ng/dl.The sample was then repeated on siemens using a different module, and the repeat result was 816 ng/dl.No questionable results were reported to the patient.
Additional Manufacturer Narrative
The testosterone ii reagent's expiration date was not provided.The cobas e 801 analytical unit serial number was (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Section b7 was updated.The calibration and qc were provided, and they were within expectations.The instrument data showed multiple reagent low alarms on the day of the event, and hinted at sample quality issues.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 22555006
• Report Number: 1823260-2025-02223
• Device Sequence Number: 13173553
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/14/2025

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 Catalogue Number: 08946370190
• Device Lot Number: 833958
• 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: 06/26/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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 Age: 61 YR
• Patient Sex: Male