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

Catalog Number	06656021190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys estradiol iii assay results for 2 patient samples on a cobas e 411 analyzer (rack system).Patient 1: the initial result was 1438 pmol/l.The repeated results were 1864 pmol/l, 2111 pmol/l, and 1625 pmol/l.Patient 2: the initial result was 791.7 pmol/l.The repeated results were 1259 pmol/l, 853.2 pmol/l, and 821.3 pmol/l.
Additional Manufacturer Narrative
The calibration and qc were acceptable.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS ESTRADIOL III ASSAY
• 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: 23644694
• Report Number: 1823260-2025-04826
• Device Sequence Number: 21244239
• Product Code: CHP
• UDI-Device Identifier: 04015630933358
• UDI-Public: 04015630933358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/19/2025

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: 01/31/2026
• Device Catalogue Number: 06656021190
• Device Lot Number: 844594
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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
• Patient Sex: Unknown