MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE

Model Number N/A

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2024

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a falsely depressed total prostate specific antigen (tpsa) patient result obtained on a dimension vista 1500 system.Siemens is investigating the event.

Event Description

A patient sample was processed and repeated on a dimension vista 1500 system.The repeat of the sample produced a falsely depressed total prostate specific antigen (tpsa) patient result.It is unknown if the falsely depressed result was reported to the physician(s).The same sample was reprocessed on an alternate dimension vista 1500 system, which recovered a higher result and matched the initial result obtained for the same sample.The initial higher result was reported as correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to falsely depressed total prostate specific antigen (tpsa) result.

• Brand Name: DIMENSION VISTA®
• Type of Device: DIMENSION VISTA® TOTAL PROSTATE SPECIFIC ANTIGEN FLEX® REAGENT CARTRIDGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #: 1226181; brookfield CT 06804 6101
• Manufacturer Contact: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18570578
• MDR Text Key: 333563160
• Report Number: 2517506-2024-00027
• Device Sequence Number: 1
• Product Code: MTF
• UDI-Device Identifier: 00842768016660
• UDI-Public: 00842768016660
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SMN 10445090
• Device Lot Number: 23192BB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male