MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM PROGESTERONE (PRGE); RADIOIMMUNOASSAY, PROGESTERONE

Model Number	N/A
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	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer complains of discordance/fluctuations in atellica im progesterone (prge) lot 330 results obtained on different days for an in-vitro fertilization (ivf) patient during their ovulation induction cycles.The customer believes that the data should gradually increase instead of fluctuating, as observed with this patient.The customer's prge empirical cutoff value (p value) is 1.5 ng/ml.The test results of this case showed that the p values exceeded 1.5 ng/ml, indicating luteinization.However, the b-ultrasound results demonstrated normal follicular growth, concluding there is an inconsistency with the clinical outcomes.The customer tested the patient with an alternate method, and the progesterone results were lower as expected.There are no allegations of adverse patient consequences in association with the event.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer complains of discordance/fluctuations in atellica im progesterone (prge) lot 330 results obtained on different days for an in-vitro fertilization (ivf) patient during their ovulation induction cycles.The customer believes that the data should gradually increase instead of fluctuating, as observed with this patient.The customer's prge empirical cutoff value (p value) is 1.5 ng/ml.The test results of this case showed that the p values exceeded 1.5 ng/ml, indicating luteinization.However, the b-ultrasound results demonstrated normal follicular growth, concluding there is an inconsistency with the clinical outcomes.The customer tested the patient with an alternate method, and the progesterone results were lower as expected.There are no allegations of adverse patient consequences in association with the event.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.Note: this mdr is filed for the result obtained on 26-dec-2025.Separate reports are submitted for the discordant results from the same patient obtained on 19-dec-2025 and 25-dec-2025.

• Brand Name: ATELLICA IM PROGESTERONE (PRGE)
• Common Device Name: RADIOIMMUNOASSAY, PROGESTERONE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032
• MDR Report Key: 24045280
• Report Number: 1219913-2026-00015
• Device Sequence Number: 21147394
• Product Code: JLS
• UDI-Device Identifier: 00630414599779
• UDI-Public: (01)00630414599779(10)23754330(17)260403
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K932955
• 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): 06/30/2026

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: 04/03/2026
• Device Model Number: N/A
• Device Catalogue Number: 10995659
• Device Lot Number: 23754330
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2025
• 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: 48 YR
• Patient Sex: Female