MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500 SYSTEM

Model Number	DIMENSION VISTA 500 SYSTEM
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a falsely depressed carbon dioxide (co2) result was obtained on a patient sample on a dimension vista 500 system.The erroneous result was not reported to the physician(s).The sample was repeated on an alternate dimension vista 500 system.The repeat result recovered higher and was considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed co2 result.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed carbon dioxide (co2) result was obtained on a patient sample on a dimension vista 500 system.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse verified and cleaned all drain and probe, replaced mixer and photometer lamp.The cse then performed alignment checks.Quality control (qc) recovered within the acceptable ranges.Siemens evaluated the event and determined that the malfunctioned mixer and photometer lamp contributed to the falsely depressed co2 result.The system is performing according to specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA 500 SYSTEM
• Common Device Name: DIMENSION VISTA 500 SYSTEM
• 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 number: 1226181; brookfield CT 06804
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23530196
• Report Number: 2517506-2025-00167
• Device Sequence Number: 13312496
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K051087
• 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): 11/12/2025

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 Model Number: DIMENSION VISTA 500 SYSTEM
• Device Catalogue Number: 10284473
• 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: 10/17/2025
• Initial Report FDA Received Date: 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2017
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown