MAUDE Adverse Event Report: Siemens Healthcare Diagnostics, Inc. Atellica IM Prostate-Specific Antigen (PSA); Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction

• Brand Name: Atellica IM Prostate-Specific Antigen (PSA)
• Common Device Name: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
• 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: 50761970
• Report Number: 1219913-2026-00174
• Device Sequence Number: 9550668
• Product Code: LTJ
• UDI-Device Identifier: 00630414599816
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P950021-S016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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 Model Number: N/A
• Device Catalogue Number: 10995663
• Device Lot Number: 26094346
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• 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: 50 YR
• Patient Sex: Male