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	09/16/2004
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained an elevated atellica im prostate-specific antigen (psa) lot: 337 result that on a patient after having received prostatic cancer treatment.The atellica im psa result was higher than expected, indicating a potential relapse.The sample was retested with alternate test methods and the results obtained were lower, in line with the patient's clinical history and were believed to be correct.There are no allegations of patient or user intervention or adverse health consequences due to the event.
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained an elevated atellica im prostate-specific antigen (psa) lot: 337 results on a patient after having received prostatic cancer treatment.The atellica im psa result was higher than expected, indicating a potential relapse.The sample was retested with alternate test methods and the results obtained were lower, in line with the patient's clinical history and were believed to be correct.There are no allegations of patient or user intervention or adverse health consequences due to 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.
Additional Manufacturer Narrative
Siemens investigated an outside of the us customer report of an elevated atellica im prostate-specific antigen (psa) lot 337 result that on a patient after having received prostatic cancer treatment.The atellica im psa result was higher than expected, indicating a potential relapse.The sample was retested with alternate test methods and the results obtained were lower, in line with the patient's clinical history and were believed to be correct.Calibration was valid and quality control (qc) recovery was within ranges.Multiple patient samples were processed for psa at the same time of the patient sample in question and no other result was questioned.The customer tested the sample with blocking tubes specific to goat, bovine and mouse.The atellica im psa result when blocking with the bovine antibodies was 0.07 ng/ml and with mouse blocking was 0.16 ng/ml indicating that these antibodies interfered with the assay.Per atellica im psa instructions for use (ifu 10997799_en rev.06, 2024-07) limitations section: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results.This assay is designed to minimize interference from heterophilic antibodies.Additional information may be required for diagnosis." based on the available information, the cause of the discordant result is consistent with heterophilic interference, and this is a patient specific issue.A product problem was not identified.Siemens filed initial mdr 1219913-2024-00446 on 23-oct-2024.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: 20514851
• Report Number: 1219913-2024-00446
• Device Sequence Number: 17942985
• Product Code: MTF
• UDI-Device Identifier: 00630414599816
• UDI-Public: (01)00630414599816(10)28703337(17)241214
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: P950021-S016
• 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): 03/27/2025

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: 12/14/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995663
• Device Lot Number: 28703337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 03/27/2025
• Date Device Manufactured: 12/14/2023
• 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: 57 YR
• Patient Sex: Male