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

Model Number	E 411
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys estradiol iii assay results from the cobas e411 rack.The initial result was >3000 pg/ml with a data flag.This result was questioned by the physician, as the estradiol result for the patient on the previous day was 2800 pg/ml.With a dilution, the repeat results were 2100 pg/ml, 2300 pg/ml, and 2500 pg/ml.The sample was then sent to another laboratory, and the result was 2900 ng/ml.This result was believed to be correct.
Additional Manufacturer Narrative
The reagent lot number was 88086800 with an expiration date of 30-jun-2026.The field service engineer checked the calibration and qc results and found all were within the expected range.He ran a precision study using qc material that passed within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation was unable to identify a specific root cause.The calibration and qc data were acceptable.The analyzer alarm trace did not contain a conspicuous event.This patient's status and the patient's ivf treatment cause unidentifiable and patient-specific metabolites that interact with the detection system of the assay and can cause cross-reactivity.A general reagent problem was not evident.The issue was only observed for certain (not all) hormonally treated ivf patients.

• 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 46250-0457
• MDR Report Key: 23876426
• Report Number: 1823260-2025-05303
• Device Sequence Number: 9605546
• 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): 02/20/2026

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 Model Number: E 411
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 02/20/2026
• 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: GANIRELIX; GONAL F; MENOPURE
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 73 KG