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	12/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 disk serial number was (b)(6).Qc was acceptable.The customer observed some debris in the sample.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 e411 immunoassay analyzer (disk system).Initial result: 3000 pg/ml (accompanied by a data flag).The data flag accompanying the initial result prompted the repeat of the sample using a dilution factor of 1:10 twice.1st repeat result: 1904 pg/ml.2nd repeat result: 1731 pg/ml.It was noted that the 2nd repeat result of 1731 pg/ml was considered to be the most accurate.
Additional Manufacturer Narrative
The provided data do not indicate an issue with the analyser or the used reagents.The investigation did not identify a product problem.The cause of the event was due to a preanalytic issue (debris was observed in the sample tube) at the customer site.Preanalytics are within the customer's responsibility.

• 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: 24057909
• Report Number: 1823260-2026-00168
• Device Sequence Number: 9745368
• Product Code: CHP
• UDI-Device Identifier: 04015630933358
• UDI-Public: 04015630933358
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 06/30/2026
• Device Catalogue Number: 06656021190
• Device Lot Number: 88086800
• 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: 12/22/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/13/2026
• 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
• Patient Age: 35 YR
• Patient Sex: Female