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	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that erroneously depressed carbon dioxide (co2) results were obtained on four patient samples on a dimension vista 500 system.Quality control (qc) was acceptable on the day of the event.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During this visit, the cse inspected the instrument and ran service methods, found a broken sample probe 1 (s1) vertical belt, replaced the belt, ran alignments, diagnostics, quick check, and qc, which recovered acceptably.The cause of the erroneously depressed co2 results is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.
Event or Problem Description
The customer reported that erroneously depressed carbon dioxide (co2) results were obtained on four patient samples on a dimension vista 500 system.Out of 4 samples, the sample with identifier (b)(6), the initial result was reported to the physician(s), who questioned the result.The samples were repeated on an alternate dimension vista 500 system.The repeat results recovered higher than the initial results and were consistent with the patient's previous reports.The repeat results were considered correct and reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed co2 results.
Additional Manufacturer Narrative
Siemens filled the initial mdr 2517506-2025-00115 on 23-jul-2025.Additional information (31-jul-2025): siemens further evaluated the event and concluded that malfunctioned s1 vertical belt potentially contributed to the erroneously depressed co2 results.The service activities provided in the initial report resolved the event.The investigation conclusion code in the h6 section was updated to reflect the additional information.The instrument is performing according to specifications.No further evaluation of this device 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: 22574556
• Report Number: 2517506-2025-00115
• Device Sequence Number: 9894340
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 08/07/2025

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: 07/03/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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