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

Catalog Number	08946353190
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	12/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer suspects an interfering factor in the patient sample.The patient sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys testosterone ii assay results for 1 patient sample on a cobas 6000 e601 module, cobas e 801 analyzer, and a competitor analyzer.The initial result was 2.38 ng/ml.Another sample collected from the patient on the same day was tested and the result was 2.50 ng/ml.The first sample was sent to another laboratory and tested on an e801 analyzer and the result was 2.31 ng/ml.All of the results were above the roche normal female reference range.The doctor questioned the results as they were inconsistent with the patient's clinical presentation.The first sample was tested on a beckman analyzer and the result was 0.363 ng/ml, which was within the normal beckman reference range.
Additional Manufacturer Narrative
On (b)(6) 2026, additional competitor analyzer results were provided for the patient sample.The patient sample was sent to another laboratory where it was tested on an abbott analyzer and the testosterone result was 67 ng/dl with flag.The abbott reference range is 11-57 ng/dl.The patient sample was received for investigation an an interfering factor could not be found.The customer's results were confirmed.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: 23839073
• Report Number: 1823260-2025-05203
• Device Sequence Number: 9599541
• Product Code: CDZ
• UDI-Device Identifier: 07613336170557
• UDI-Public: 07613336170557
• 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): 02/26/2026

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: 06/30/2026
• Device Catalogue Number: 08946353190
• Device Lot Number: 851750
• 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: 12/06/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/26/2026
• 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 Age: 26 YR
• Patient Sex: Female