MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® V-LYTE® INTEGRATED MULTISENSOR NA+ K+ CL-

Catalog Number	K800A SMN 10484429
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A discordant falsely elevated sodium (na) patient sample result was obtained on a dimension vista 1500 system.The falsely elevated result was not reported to the physician.The same sample was reprocessed on an alternate dimension vista 1500 system and on the original dimension vista 1500 system.Lower results, considered correct, were obtained.The lower reprocessed result from the alternate dimension vista 1500 system was reported as the correct result to the physician.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated sodium (na) result.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding a falsely elevated sodium (na) patient sample result obtained on a dimension vista 1500 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer.Quality control (qc) recovery was within the customer's expected ranges.The customer observed the low integrated multisensor technology (imt) consumables.The issue was resolved with standard troubleshooting and maintenance procedures performed by the customer, including replacement of the low imt standard a and standard b fluids and performing imt priming.Hsc concluded the cause of the event is consistent with a low fluid flow issue.A potential product issue was not identified.The system is fully operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® V-LYTE® INTEGRATED MULTISENSOR NA+ K+ CL-
• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 17974531
• Report Number: 2517506-2023-00223
• Device Sequence Number: 2454144
• Product Code: JGS
• UDI-Device Identifier: 00842768030413
• UDI-Public: 00842768030413
• Combination Product (Y/N): N
• 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): 10/20/2023

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: 11/11/2023
• Device Catalogue Number: K800A SMN 10484429
• Device Lot Number: 3ED813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/20/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown