MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ENHANCED ESTRADIOL (EE2); RADIOIMMUNOASSAY, ESTRADIOL

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).Siemens was notified of elevated atellica im enhanced estradiol (ee2) lot 107 results obtained on serum samples from a postmenopausal 63-year-old female.These results were obtained pre and post oophorectomy and were discordant relative to lower alternate method test results and other diagnostic testing.The atellica im ee2 result obtained prior to the oophorectomy was not questioned at the time.The physician who performed the post-operative check-up on the patient (19-feb-2026) questioned the results and believes that the oophorectomy was an unnecessary medical procedure (oophorectomy, (b)(6) 2026).The assay's instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.This report is submitted for sample id (b)(6), tested (b)(6) 2026.A separate report is submitted for sample id (b)(6), tested (b)(6) 2025.
Event or Problem Description
Siemens was notified of elevated atellica im enhanced estradiol (ee2) lot 107 results obtained on serum samples from a postmenopausal 63-year-old female.These results were obtained pre and post oophorectomy and were discordant relative to lower alternate method test results and other diagnostic testing (positron emission tomography-computed tomography (pet-ct) with no findings in (b)(6) 2025).The atellica im ee2 result obtained prior to the oophorectomy was not questioned at the time.The physician who performed the post-operative check-up on the patient ((b)(6) 2026) questioned the results and believes that the oophorectomy was an unnecessary medical procedure (oophorectomy, (b)(6) 2026).

• Brand Name: ATELLICA IM ENHANCED ESTRADIOL (EE2)
• Common Device Name: RADIOIMMUNOASSAY, ESTRADIOL
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney st.; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24684147
• Report Number: 1219913-2026-00063
• Device Sequence Number: 21307955
• Product Code: CHP
• UDI-Device Identifier: 00630414598857
• UDI-Public: (01)00630414598857(10)87409107(17)260607
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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): 07/07/2026

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: 06/07/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 87409107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female