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)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e411 rack serial number was (b)(6).The field service engineer performed preventive maintenance and performed estradiol dilution on a patient sample for troubleshooting.Qc and precision testing passed.The investigation was unable to determine a specific root cause.A general reagent issue was not found.
Event or Problem Description
There was an allegation of questionable elecsys estradiol iii assay results from the cobas e411 rack analyzer.The initial result was >3000 pg/ml with a data flag.The repeat result with a 1:10 dilution was 2322 pg/ml.The sample was repeated without a dilution, and the result was >3000 pg/ml with a data flag.The repeat result with a 1:10 dilution was 2268 pg/ml.The result with a manual 1:10 dilution that was tested on the instrument with no autodilution was 2884 pg/ml.The result with a 1:2 dilution was 2634 pg/ml.The result with a 1:5 dilution was 2614 pg/ml.The result of 2884 pg/ml was believed to be correct.

• 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: 23036513
• Report Number: 1823260-2025-02849
• Device Sequence Number: 9514854
• 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
• Report Date (Section B): 09/12/2025

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: 84459400
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 09/12/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FOLLISTIM.; GANIRELIX.; MENOPUR.; SERTRALINE.
• Patient Sex: Female