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

Catalog Number	07027249190
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	10/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas pure e 402 analytical unit serial number was (b)(6).No calibration influence was observed.The qc was within range prior to the sample measurement.No relevant alarms were observed.The field service engineer exchanged the reagent probe and fixed the reagent cover.The analyzer was performing within specifications.Dirt/dust was observed on several analyzer parts, including the reagent probe wash station and dusty surfaces.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested with elecsys estradiol iii assay on a cobas pure e 402 analytical unit.Initial result: 740 pg/ml.1st repeat result: 49.1 pg/ml.2nd repeat result: 48.4 pg/ml.On (b)(6) 2025: the sample was repeated on a delta instrument, resulting in a 3rd repeat result of 57.2 pg/ml.The sample was repeated 10 more times on a different cobas pure analytical unit, resulting in the following repeat results: 46.2 pg/ml, 51.2 pg/ml, 47.9 pg/ml, 46.6 pg/ml, 47.4 pg/ml, 46.8 pg/ml, 47.2 pg/ml, 46.4 pg/ml, 48.3 pg/ml, and 47.2 pg/ml.The result that was considered correct was around 50 pg/ml.
Additional Manufacturer Narrative
As the provided pictures showed dirt/dust on several analyzer parts, the root cause was consistent with an operator maintenance issue where insufficient/incorrect execution was performed.The investigation did not identify a product problem.

• 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: 23622046
• Report Number: 1823260-2025-04793
• Device Sequence Number: 10090536
• Product Code: CHP
• UDI-Device Identifier: 04015630939671
• UDI-Public: 04015630939671
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 12/09/2025

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: 04/30/2026
• Device Catalogue Number: 07027249190
• Device Lot Number: 858578
• 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: 10/28/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/09/2025
• 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