MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA V-LYTE INTEGRATED MULTISENSOR NA+ K+ CL-; ELECTRODE, ION SPECIFIC, SODIUM

Model Number	N/A
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens they obtained an erroneously depressed sodium (na) result on one (1) patient sample on the dimension vista 500 system.The erroneously depressed result was reported to the physician and questioned.This sample could not be reprocessed due to quantity not sufficient.A new sample was drawn and processed on an alternate dimension vista 500 system.A higher result was obtained, considered correct, and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed sodium (na) result.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed sodium (na) result on one (1) patient sample on a dimension vista 500 system.Siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos evaluated the information provided by the customer.No reagent or instrument issues were identified.Quality control (qc) recovered within the customer¿s laboratory ranges at the time of the event.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA V-LYTE INTEGRATED MULTISENSOR NA+ K+ CL-
• Common Device Name: ELECTRODE, ION SPECIFIC, SODIUM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer Contact: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 22954560
• Report Number: 2517506-2025-00139
• Device Sequence Number: 9636241
• Product Code: JGS
• UDI-Device Identifier: 00842768030413
• UDI-Public: (01)00842768030413(10)5CD807(17)250927
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/03/2025

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 Expiration Date: 09/27/2025
• Device Model Number: N/A
• Device Catalogue Number: 10484429
• Device Lot Number: 5CD807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/31/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown