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

Catalog Number	07027249190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of interference from medication affecting an elevated elecsys estradiol iii result from two cobas e 801 analytical units for one patient.The patient's result on (b)(6) 2026 from analyzer a was 3087 pmol/l, using reagent lot number 858578.The patient's result on (b)(6) 2026 from analyzer b was 3373 pmol/l, using reagent lot number 858578.The patient's result on (b)(6) 2026 was 1832 pmol/l, using reagent lot number 887565.It was not provided which analyzer this result was from.This sample was sent to another hospital that uses a siemens analyzer, and the result was 1782 pmol/l.The siemens result was comparable to the roche result.
Additional Manufacturer Narrative
The cobas e 801 analytical unit a serial number is (b)(6).The cobas e 801 analytical unit b serial number is (b)(6).The patient sample has been requested for investigation.The investigation is ongoing.

• 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: 25125875
• Report Number: 1823260-2026-01810
• Device Sequence Number: 18294292
• Product Code: CHP
• UDI-Device Identifier: 04015630939671
• UDI-Public: 04015630939671
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/08/2026

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, 858578
• 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: 04/16/2026
• Supplement Date Received by Manufacturer: 06/22/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 07/08/2026
• 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 Age: 51 YR
• Patient Sex: Female