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	01/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two erroneously elevated results on one patient sample obtained with total prostate specific antigen (tpsa) on a dimension exl 200 system.Multiple mdrs are being filed for the same event.Siemens is investigating the event.
Event or Problem Description
The customer reported two (2) erroneously elevated total prostate specific antigen (tpsa) results from the same patient sample obtained on a dimension exl 200 system.The erroneously elevated sample results were reported to the physician and not questioned.The same sample was processed on an alternate siemens atellica im 1300 analyzer at an alternate facility.A lower result was obtained, considered correct, and reported to the physician.Due to the erroneously elevated total prostate specific antigen (tpsa) results, the patient had multiple repeat blood tests performed and a positron emission tomography (pet) scan.There was no harm caused to the patient due to the erroneously elevated total prostate specific antigen (tpsa) results.
Additional Manufacturer Narrative
Additional information (18-feb-2025): 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.Quality control (qc) recovery was within the customer¿s acceptable ranges.The customer tested the patient sample with a heterophilic blocking tube (hbt) and a non-specific antibody blocking tube (nabt) and tested in duplicate (n: 2) on a dimension exl 200 system.The results revealed the presence of heterophilic antibodies and non-specific antibodies.The probable cause of the issue is consistent with heterophilic antibodies and non-specific antibody interference present in this patient sample.No reagent or instrument issues were identified.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Section h10 was updated with the related report numbers filed for this issue.Initial mdr 2517506-2025-00023 was filed on 12-feb-2025.Initial mdrs 2517506-2025-00021, 2517506-2025-00022, and 2517506-2025-00024 were also filed on 12-feb-2025 for the same event.

• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 21367616
• Report Number: 2517506-2025-00023
• Device Sequence Number: 8519205
• Product Code: MTF
• UDI-Device Identifier: 00842768013874
• UDI-Public: (01)00842768013874(10)FA5242(17)250830
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 03/06/2025

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: 08/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 10444889
• Device Lot Number: FA5242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/26/2024
• 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: 65 YR
• Patient Sex: Male