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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained elevated atellica im enhanced estradiol (ee2) lot 106 results on (b)(6) 2025 on serum samples from a postmenopausal 63-year-old female.The elevated atellica im ee2 results were not questioned at the time as the patient was referred to this customer site for confirmation testing only.The patient was later tested at a hospital laboratory ((b)(6) 2026) with an alternate estradiol method and a positron emission tomography-computed tomography (pet-ct) was performed with no findings.The patient ultimately underwent oophorectomy ((b)(6) 2026) and the physician who performed the post-operative check-up on the patient ((b)(6) 2026) believes that the oophorectomy was an unnecessary medical procedure.Subsequently, siemens has been notified that the results obtained by this customer on (b)(6) 2025 are now in question.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.
Event or Problem Description
The customer obtained elevated atellica im enhanced estradiol (ee2) lot 106 results on(b)(6) 2025 on serum samples from a postmenopausal 63-year-old female.The elevated atellica im ee2 results were not questioned at the time as the patient was referred to this customer site for confirmation testing only.The patient was later tested at a hospital laboratory ((b)(6) 2026) with an alternate estradiol method and a positron emission tomography-computed tomography (pet-ct) was performed with no findings.The patient ultimately underwent oophorectomy ((b)(6) 2026) and the physician who performed the post-operative check-up on the patient ((b)(6) 2026) believes that the oophorectomy was an unnecessary medical procedure.Subsequently, siemens has been notified that the results obtained by this customer on (b)(6) 2025 are now in question.

• 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.; 511 benedict ave; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24711772
• Report Number: 1219913-2026-00064
• Device Sequence Number: 5777351
• Product Code: CHP
• UDI-Device Identifier: 00630414598857
• UDI-Public: (01)00630414598857(10)43423106(17)260301
• 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: 03/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995561
• Device Lot Number: 43423106
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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