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

Catalog Number	07027249190
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	04/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's e 801 analyzer is (b)(6).It was asked, but the serial number of the unknown roche analyzer is not known.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable results for two samples collected from the same patient and tested with elecsys estradiol iii on a cobas e 801 analytical unit and an unknown roche analyzer at a second site.The first sample resulted in an estradiol value of 105 pg/ml when tested on the customer's e 801 analyzer.The patient's doctor questioned the value as the patient had a history of breast cancer.The patient had undergone a mastectomy and bilateral oophorectomy.The estradiol result was expected not to be measurable.The first sample was sent to another laboratory where it was tested using the same roche method on an unknown analyzer.The estradiol result was the same.No specific data was provided.A second sample collected from the patient resulted in an estradiol value of 161 pg/ml on (b)(6) 2026.This sample was sent to another laboratory for testing with the abbott estradiol method.When tested with the abbott method, the estradiol result was < 20 pg/ml.

• 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: 25432238
• Report Number: 1823260-2026-02259
• Device Sequence Number: 16003825
• Product Code: CHP
• UDI-Device Identifier: 04015630939671
• UDI-Public: 04015630939671
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2026

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 Catalogue Number: 07027249190
• Device Lot Number: 887565
• 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: 05/22/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 06/24/2026
• 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: Unknown