MAUDE Adverse Event Report: Siemens Healthcare Diagnostics Inc. Atellica IM; Atellica IM Prostate-Specific Antigen (PSA)

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	07/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported an observation of a falsely depressed atellica im prostate specific antigen (psa) result, which was discordant relative to repeat testing when using lot 347.The initial result was reported to the physician(s).The sample was reprocessed on the original analyzer.The repeat result recovered higher than the initial result and fitted the patient¿s history.The repeat result was reported as correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to this event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported an observation of a falsely depressed atellica im prostate specific antigen (psa) result, which was discordant relative to repeat testing.The customer indicated that the sample was run while the tube cap was still in place.The customer also noted there were no decapper errors that occurred prior to sample being tested.Siemens reviewed instrument data and the information provided by the customer and ruled out reagent and instrument related issues based on review of qc, which showed recovery within acceptable ranges, no abnormalities associated with sample aspiration or reagent dispensing, and no issues were reported with other patient samples.However, it was identified that the sample tube size was different when comparing the first aspiration of this sample identifier versus the repeat.Return of the patient sample for further investigation is not warranted because discordant results were not reproducible.Siemens further evaluated the event and determined that the probable cause of the discordant result is consistent with a sample handling issue.A product issue was not identified.The customer is operational after repeating the sample without the cap.

• Brand Name: Atellica IM
• Common Device Name: Atellica IM Prostate-Specific Antigen (PSA)
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; +919(870)577433
• MDR Report Key: 50401165
• Report Number: 1219913-2026-00164
• Device Sequence Number: 10560002
• Product Code: MTF
• UDI-Device Identifier: 00630414599809
• UDI-Public: (01)00630414599809(10)50269347(17)20270129
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

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: 10995662
• Device Lot Number: 50269347
• 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: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• 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