MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION® TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE; 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	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated total prostate specific antigen (tpsa) result on a patient plasma sample on a dimension exl 200 integrated chemistry system.The serum sample for the same patient was processed on an alternate non-siemens method at an alternate site.A lower result was obtained, considered correct, and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated total prostate specific antigen (tpsa) result.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated total prostate specific antigen (tpsa) result on a patient plasma sample on the dimension exl 200 integrated chemistry system.Quality control was in range at the time of the event.Siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos evaluated the information provided by the customer and the available instrument data.No reagent or instrument issues were identified.The cause of the event is unknown.Siemens does not have claims on correlation with other analyzers which use alternate methodology for analyte measurement.As the technology used by analyzers were different, there should not be any numerical comparison between the analyzers.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.

• Brand Name: DIMENSION® TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE
• Common Device Name: TOTAL, PROSTATE SPECIFIC ANTIGEN (NONCOMPLEXED & COMPLEXED) FOR DETECTION OF PRO
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 22012062
• Report Number: 2517506-2025-00076
• Device Sequence Number: 5192780
• Product Code: MTF
• UDI-Device Identifier: 00842768013874
• UDI-Public: (01)00842768013874(10)FA6008(17)260108
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P000021
• 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): 05/13/2025

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: 01/08/2026
• Device Model Number: N/A
• Device Catalogue Number: 10444889
• Device Lot Number: FA6008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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: 61 YR
• Patient Sex: Male