MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500

Model Number	DIMENSION VISTA 500
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens customer care center (ccc) and reported that erroneously elevated carbon dioxide (co2) results on multiple patient samples were obtained on a dimension vista 500 instrument.Quality controls (qc's) were within range prior to running patient samples.Customer performed the probe and drain maintenance for reagent arm 1, reagent arm 2, sample probe 1 and integrated multisensor technology (imt) probe.The customer then ran qc, which recovered acceptably.Siemens remotely assisted the customer and performed alignments for reagent arm 1, reagent arm 2, sample arm 1, imt and imt probe which passed successfully, then performed quick system check which also passed successfully.Further, the customer ran qc which recovered acceptably.The instrument was performing within specifications.Siemens is evaluating the event.
Event or Problem Description
The customer reported that erroneously elevated carbon dioxide (co2) results were obtained on multiple patient samples on a dimension vista 500 instrument.The initial results were not reported to the physician(s).The sample identifiers (b)(6) were repeated on the original instrument and were considered erroneous.All the samples were repeated on an alternate dimension vista 500 instrument, except the sample identifier 3865973, which was repeated thrice on an alternate dimension vista 500 instrument.The repeat results recovered lower than the initial result and were in normal range.The repeat results were considered correct and reported to the physician(s).For sample identifier (b)(6), a result of 28 mmol/l was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated co2 results.
Additional Manufacturer Narrative
Siemens filed initial mdr 2517506-2025-00121 on 01-aug-2025.Additional information (26-aug-2025): in addition to the service activities mentioned in the initial report, the customer ran 15 prime cycles, which passed acceptably.Siemens observed water quality issues such as calibration drift and persistent low outliers from the middle of the well as indicators of poor water quality.Siemens further evaluated the event and determined that the contamination or blockage within the instrument potentially contributed to the falsely elevated carbon dioxide (co2) results.The investigation findings and investigation conclusions codes in section h6 were updated to reflect additional information.The instrument was performing within specifications.No further evaluation of this device is required.

• Brand Name: DIMENSION VISTA 500
• Common Device Name: DIMENSION VISTA 500
• 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: 22684671
• Report Number: 2517506-2025-00121
• Device Sequence Number: 21194129
• Product Code: JJE
• UDI-Device Identifier: 00630414949581
• UDI-Public: (01)00630414949581
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/09/2025

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
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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