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	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of discrepant results for 1 patient sample tested for elecsys testosterone ii assay (testosterone ii), elecsys estradiol iii (estradiol iii), and elecsys prolactin ii (prolactin ii) on a cobas e 801 analytical unit compared to the siemens method and liquid chromatography¿mass spectrometry (lc-ms).This medwatch will cover testosterone ii.Refer to medwatch with a1 patient identifier (b)(6) for information on the estradiol iii results and medwatch with a1 patient identifier (b)(6) for information on the prolactin ii results.The testosterone ii result from the e801 analyzer was 52.0 nmol/l.The result from the siemens method was 25 nmol/l.The lc-ms result was 17.7 nmol/l.The estradiol iii result from the e801 analyzer was 474 pmol/l.The result from the siemens method was 0.16 pmol/l.The prolactin ii result from the e801 analyzer was 265 mu/l.The result from the siemens method was 0.17 iu/l.
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).

• 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: 24877022
• Report Number: 1823260-2026-01420
• Device Sequence Number: 12992195
• Product Code: CDZ
• UDI-Device Identifier: 07613336170571
• UDI-Public: 07613336170571
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 06/15/2026

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: 03/24/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/15/2026
• 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: CITALOPRAM - 1X/DAY; QUETIAPINE - 1X/DAY
• Patient Age: 60 YR
• Patient Sex: Male