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

Catalog Number	07027249190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys estradiol iii results for 1 patient sample on a cobas 8000 e 801 module.The initial result was 19.4 pg/ml.The physician questioned the result, and the sample was repeated on another e 801 module.The repeated result was 19.4 pg/ml.Neither result was believed to be correct because a higher result was expected for the patient.The sample was repeated with a 1:2 dilution, and the result was "still in line with the undiluted measurements." the numerical result was not provided.The sample was repeated with a 1:10 dilution, and the result was 250 pg/ml.This result was believed to be correct.
Additional Manufacturer Narrative
A service visit was not required.Instrument hardware performance issues were ruled out by the customer by obtaining the same result from both analyzers due to insufficient information, the investigation could not identify a specific cause of the event.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: 23850159
• Report Number: 1823260-2025-05232
• Device Sequence Number: 21225400
• Product Code: CHP
• UDI-Device Identifier: 04015630939671
• UDI-Public: 04015630939671
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/30/2026

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: 08/31/2026
• Device Catalogue Number: 07027249190
• Device Lot Number: 88756501
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/30/2026
• 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 Sex: Female