MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM PROSTATE SPECIFIC ANTIGEN (PSA); PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER

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	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from outside the united states reported observation of a depressed prostate specific antigen (psa) result which was discordant relative to clinical expectation and repeat testing.There were no issues noted with either calibration or quality control (qc) data.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 evaluating this issue.
Event or Problem Description
The customer reports observation of a depressed atellica im prostate specific antigen (psa) result which was discordant relative to repeat testing.An initial depressed prostate specific antigen (psa) result was obtained for a 67-year-old male patient when tested with psa lot 337.The result was not reported to the physician(s).The same sample was repeated on two different atellica im analyzers, producing higher results.The higher results were considered correct as they were in agreement with the clinical picture for the patient, and a corrected report was issued based on the repeat testing.There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
Mdr 1219913-2024-00371 was initially filed on 25-jul-2024.Additional information 23-aug-2024: siemens has concluded the investigation for the issue reported by a customer outside of the us regarding a discordant psa patient result vs.Repeat testing on alternate atellica im analyzers.Siemens evaluated the atellica im system files and customer data.The analyzer generated the following error messages "bubble found" and "tube top sample cup checks failed during sample processing.These error messages indicate that are consistent with a sample integrity issue.The return of the sample for further investigation by siemens because the discordant result was not reproducible.The cause of the discordant result was consistent with preanalytical variables, and the reported issue was resolved by routine troubleshooting.The customer is operational, and no further action is required.Note: in section h6, the codes for investigation findings and investigation conclusions have been updated.

• Brand Name: ATELLICA IM PROSTATE SPECIFIC ANTIGEN (PSA)
• Common Device Name: PROSTATE SPECIFIC ANTIGEN FOR DETECTION OF PROSTATE CANCER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; registration # 1219913; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 333 coney st.; east walpole, MA 02032 ; 5082985306
• MDR Report Key: 19823343
• Report Number: 1219913-2024-00371
• Device Sequence Number: 8781149
• Product Code: MTF
• UDI-Device Identifier: 00630414599816
• UDI-Public: 00630414599816
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P950021-S016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 09/12/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Male