MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA); TOTAL, PROSTATE SPECIFIC ANTIGEN (NONCOMPLEXED & COMPLEXED) FOR DETECTION OF PRO

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	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a discordance between neat and diluted atellica im prostate-specific antigen (psa) lot 342 results on one patient sample.The initial neat result of 65.42 ng/ml was obtained, and the customer then tested the sample by dilution to rule out a potential hook effect.The diluted results were higher by more than 15% than the neat result, but within the assay analytical measuring range (amr).The customer reported only the initial result as correct, and it was not questioned by the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with this event.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer observed a discordance between neat and diluted atellica im prostate-specific antigen (psa) lot 342 results on one patient sample.The initial neat result of 65.42 ng/ml was obtained, and the customer then tested the sample by dilution to rule out a potential hook effect.The diluted results were higher by more than 15% than the neat result, but within the assay analytical measuring range (amr).The customer reported only the initial result as correct, and it was not questioned by the physician.Quality control (qc) was acceptable at the time of testing.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.
Additional Manufacturer Narrative
Siemens filed initial mdr 1219913-2025-00116 on 16-jun-2025.Siemens has completed the investigation for an outside of the united states (ous) customer observation of a discordance between neat and diluted atellica im prostate-specific antigen (psa) lot: 342 results on one patient sample.The customer processed the patient sample undiluted, and it resulted 65.42 ng/ml.The customer diluted the sample onboard x5, x10 and x100 using multi-diluent 2 to eliminate a possible hook incident.The diluted results were higher, but within the assay analytical measuring range (amr) and reported as correct.Psa lot: 342 reagent issues were ruled out based on review of quality control (qc) data, which showed recovery within acceptable ranges and no issues were reported with other patient samples.Assessment of the atellica im analyzer performance included a review of additional patient samples that were diluted on the same day as the sample in question and results were acceptable and not questioned by physicians.Return of the patient sample for further investigation is not warranted because the customer has conducted appropriate testing (verifying result by dilutions).A review of escalations from the past year conducted on 01-july-2025, did not identify investigations of a similar nature with psa lot: 342 and dilution recovery.Based on the available information, the cause of the discordant low result appears to be a patient specific issue.Customer has not had any similar issues and is operational by verifying psa dilution performance.In section h6 of this report, the investigation finding and conclusion codes were updated based on the investigation results.

• Brand Name: ATELLICA IM PROSTATE-SPECIFIC ANTIGEN (PSA)
• Common Device Name: TOTAL, PROSTATE SPECIFIC ANTIGEN (NONCOMPLEXED & COMPLEXED) FOR DETECTION OF PRO
• 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: 22213152
• Report Number: 1219913-2025-00116
• Device Sequence Number: 12795098
• Product Code: MTF
• UDI-Device Identifier: 00630414599816
• UDI-Public: (01)00630414599816(10)65173342(17)251101
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P950021-S015
• 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): 07/25/2025

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: 11/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995663
• Device Lot Number: 65173342
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2024
• 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 Sex: Male