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	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This incident occurred outside the united states (ous).The ous customer obtained an initial elevated atellica im psa lot 340 result on a serum sample from a 58-year-old male patient (post-prostatectomy) that was lower upon retesting.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.
Event or Problem Description
The customer obtained an elevated atellica im psa lot 340 result on a serum sample from a 58-year-old male patient (post-prostatectomy).The elevated result was reported and questioned by the physician.The customer retested the sample on the same atellica im analyzer and a different atellica im analyzer.Both results were lower, as expected.A corrected report was issued.The patient was also sent to another laboratory for alternate method testing and the result was low, as expected.There are no reports of altered treatment or adverse health consequences due to the event.
Additional Manufacturer Narrative
Siemens investigated a customer report of an elevated atellica im psa lot: 340 result on a serum sample from a 58-year-old male patient (post-prostatectomy) that was lower upon retesting and believed to be correct.Customer calibration was valid and quality control (qc) recovery acceptable the day of the discordant result.Siemens reviewed the reagent and probe trace files provided for the date of the event and there was no evidence of a hardware or sample probe issue that impacted delivery of psa reagents or sample.The discordant result was not reproducible.The discordant elevated result was not reproducible.Based on the available information and investigation results, the cause of the discordant result could not be determined.The customer is operational, and the reported issue is resolved by routine troubleshooting.Siemens filed mdr 1219913-2024-00458 on 30-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: 20568027
• Report Number: 1219913-2024-00458
• Device Sequence Number: 7816361
• Product Code: MTF
• UDI-Device Identifier: 00630414599809
• UDI-Public: (01)00630414599809(10)08859340(17)250709
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/20/2025

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: 07/09/2025
• Device Model Number: N/A
• Device Catalogue Number: 10995662
• Device Lot Number: 08859340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 02/20/2025
• Date Device Manufactured: 07/09/2025
• 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: 58 YR
• Patient Sex: Male