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	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported that a falsely depressed carbon dioxide (co2) result was obtained on a patient sample on a dimension vista 1500 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc evaluated the information provided by the customer and reviewed the field service report (fsr).A siemens customer service engineer (cse) was dispatched to the customer's site.The cse performed a co2 precision study, and the results were acceptable.The customer recalibrated the co2 assay, performed an integrated multisensor technology (imt) advance clean, and replaced the sensor.Quality control (qc) recovered within the customer's expected ranges.Hsc concluded that the probable cause of the falsely depressed co2 result was due to the calibration.The issue was resolved by recalibrating the reagent lot.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
A falsely depressed carbon dioxide (co2) result was obtained on a patient sample on a dimension vista 1500 system.The falsely depressed result was not reported to the physician(s).The customer reprocessed the same sample on an alternate dimension vista 1500 system.The reprocessed result recovered higher than the initial depressed result.The reprocessed result was reported as the correct result to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the falsely depressed co2 result.

• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 18815385
• Report Number: 2517506-2024-00086
• Device Sequence Number: 8308369
• Product Code: KHS
• UDI-Device Identifier: 00842768015625
• UDI-Public: 00842768015625
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/01/2024

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: 06/27/2024
• Device Model Number: N/A
• Device Catalogue Number: K1137 SMN 10445163
• Device Lot Number: 23179BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• 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