MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	10284473
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three samples gave falsely depressed carbon dioxide (co2) test results on a dimension vista 500.A siemens operational support (sos) specialist connected remotely to the customer site and determined all the impacted tests were on server 1.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the dimension vista 500.The cse replaced the r1 mixer and replaced and aligned the r1 and r2 probes.The cse also replaced the sample drain and primed the sample probe.Quality control materials were run with acceptable results.The cause of the discordant co2 and bun test results is unknown.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
Three samples gave falsely depressed carbon dioxide (co2) test results on a dimension vista 500.The initial test results were released to the physician(s).The same samples were repeated on the same dimension vista 500 and corrected reports were released to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the behavior.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; registration number: 1226181; brookfield CT 06804
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 22078775
• Report Number: 2517506-2025-00082
• Device Sequence Number: 8703367
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 05/23/2025

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: 10284473
• 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: 05/16/2025
• Initial Report FDA Received Date: 05/23/2025
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown