MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; DIMENSION VISTA® CARBON DIOXIDE FLEX® REAGENT CARTRIDGE

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	04/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneously depressed carbon dioxide (co2) results obtained on two (2) patient samples on a dimension vista 1500 intelligent lab system.The customer observed that the co2 flex was at the end of the wells and replaced the low-volume flex with a new one.Siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the instrument data files and the information provided by the customer.Calibration was acceptable, and quality control (qc) recovered within range on the event date.Based on the available information, siemens determined that there were no issues with the co2 assay or the dimension vista 1500 intelligent lab system.The cause of the event is unknown.The issue was resolved by reprocessing the samples as part of standard troubleshooting procedure.A product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that erroneously depressed carbon dioxide (co2) results were obtained on two (2) patient samples on a dimension vista 1500 intelligent lab system.The erroneously depressed results were not reported to the physician(s), as the customer identified and corrected them before the physician(s) became aware, even though the results had been entered into the laboratory information system (lis).The same samples were reprocessed on an alternate dimension vista 1500 intelligent lab system.The reprocessed results recovered higher than the erroneous results.The higher reprocessed results were reported as the correct results to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed carbon dioxide (co2) results.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® CARBON DIOXIDE FLEX® REAGENT CARTRIDGE
• 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 22043144
• Report Number: 2517506-2025-00079
• Device Sequence Number: 9061262
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: (01)00842768015625(10)24260BB(17)250916
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K061238
• 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): 05/19/2025

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: 09/16/2025
• Device Model Number: N/A
• Device Catalogue Number: K1137 SMN 10445163
• Device Lot Number: 24260BB
• 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: 04/25/2025
• Initial Report FDA Received Date: 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2024
• 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