MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ESTRADIOL III; RADIOIMMUNOASSY, ESTRADIOL

Catalog Number	07027249190
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
Additional Manufacturer Narrative
The e801 analyzer serial number was (b)(6).
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 estradiol iii.Refer to medwatch with a1 patient identifier pt-(b)(6) for information on the testosterone ii results and medwatch with a1 patient identifier pt-(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.

• Brand Name: ELECSYS ESTRADIOL III
• Common Device Name: RADIOIMMUNOASSY, ESTRADIOL
• 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: 24877123
• Report Number: 1823260-2026-01422
• Device Sequence Number: 10039201
• Product Code: CHP
• UDI-Device Identifier: 04015630939671
• UDI-Public: 04015630939671
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K965109
• 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: 08/31/2026
• Device Catalogue Number: 07027249190
• Device Lot Number: 887565
• 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