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	11/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted siemens to report a falsely depressed calcium test result was obtained on one patient sample from a dimension vista 500 analyzer.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse performed service on the sample (s1) mixer, the sample (s1) arm and the reagent (r1) arm.The service included replacing timing belts, the s1 arm and the r1 arm.The cse performed alignments of the s1 mixer, s1 arm and the r1 arm.Quality control materials were run with acceptable results.The cause of the falsely depressed calcium test result is unknown.Timing belts and mechanical alignments are potential contributing factors.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
A falsely depressed calcium test result was obtained on one patient sample from a dimension vista 500 analyzer.The initial test result was not released.The same sample was repeated on an alternate dimension vista 500 analyzer.The repeat result was considered correct and released to a physician.There are no known reports of patient intervention or adverse health consequences due to the event.

• 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; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550571
• MDR Report Key: 23559719
• Report Number: 2517506-2025-00173
• Device Sequence Number: 10108154
• 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): 11/14/2025

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: 11/02/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown