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

Catalog Number	08946370190
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	11/20/2024
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 high results for 1 patient tested for elecsys testosterone ii assay (testosterone ii) on a cobas e 801 analytical unit.The customer has been monitoring the patient¿s testosterone ii results for 1 month.The patient had been taking rectal cannabigerol (cbg) during this 1 month period; the last dose was on (b)(6) 2024.On (b)(6) 2024 the result was 30.7 nmol/l.On (b)(6) 2024 the result was 19.4 nmol/l.On (b)(6) 2024 the result was 30.6 nmol/l.On (b)(6) 2024 the result was 16.3 nmol/l.The customer suspects an interference with the cbg therapy.
Additional Manufacturer Narrative
Sample material from the patient was tested for investigation using a cobas e801 analyzer, lc-ms technology, and a siemens centaur analyzer.The customer's elecsys testosterone ii assay results were confirmed.No known interfering factor was found.The investigation did not identify a product problem.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21114922
• Report Number: 1823260-2025-00073
• Device Sequence Number: 7679978
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• 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): 02/20/2025

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: 09/30/2025
• Device Catalogue Number: 08946370190
• Device Lot Number: 794958
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CANNABIGEROL (CBG) ¿ 1MG/DAY.; ELIGARD.
• Patient Sex: Male