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

Catalog Number	06656021190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 rack serial number was (b)(6).The qc recovery was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation regarding discrepant results for 1 patient sample tested with elecsys estradiol iii assay on a cobas e411 immunoassay analyzer (rack system).Initial result: >3000 pg/ml (accompanied by a data flag).1st repeat result: 2192 pg/ml (repeated automatically by the analyzer with a dilution of 1:10).2nd repeat result: >3000 pg/ml (accompanied by a data flag).3rd repeat result: 2240 pg/ml (tested with a dilution of 1:10).The 3rd repeat result was deemed correct and reported outside the laboratory.The analyzer's auto-rerun and issues with dilution prompted the reruns of the patient sample.
Additional Manufacturer Narrative
Section d4 was updated.The alarm trace showed a sample volume insufficient or a clot alarm.The field service engineer reviewed dilution handling with the customer per the product labeling and performed preventive maintenance.Precision studies and qc were performed, and they were within specifications.The product labeling states: "dilution samples with estradiol concentrations above the measuring range can be diluted with diluent multiassay.The recommended dilution is 1:10 (automatically by the analyzers).The concentration of the diluted sample must be > 881 pmol/l (> 240 pg/ml)." 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: 22920578
• Report Number: 1823260-2025-02661
• Device Sequence Number: 21388185
• Product Code: CHP
• UDI-Device Identifier: 04015630933358
• UDI-Public: 04015630933358
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/29/2025

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: 84459401
• 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: 08/05/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 09/29/2025
• 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 Age: 40 YR
• Patient Sex: Female