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	09/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys testosterone ii assay results for 1 patient sample on a cobas e 801 analytical unit.The initial result was 6.76 nmol/l.The sample was repeated on a competitor analyzer and the result was 0.45 nmol/l.The initial result was inconsistent with the patient's clinical picture.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The patient sample was requested for investigation.The investigation is ongoing.
Additional Manufacturer Narrative
Section d product information has been updated.The calibration and qc recovery data provided was within specification.The patient sample was received for investigation.The investigation did not identify an interfering factor in the sample.The customer's results were confirmed.Per product labeling, "implausible elevated testosterone values in women should be verified by an extraction method or a validated lc-ms/ms tandem method." "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings." 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 46250-0457
• MDR Report Key: 23359036
• Report Number: 1823260-2025-04293
• Device Sequence Number: 8888377
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 03/19/2026

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): Initial
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 03/19/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CIMZIA.
• Patient Age: 31 YR
• Patient Sex: Female