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

Catalog Number	K2038 SMN 10464356
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding six (6) erroneous creatine kinase (cki) results obtained on a patient sample on a dimension vista 500 intelligent lab system.Siemens is evaluating the event.
Event or Problem Description
The customer reported to siemens that they obtained six (6) erroneous creatine kinase (cki) results on a patient sample on a dimension vista 500 intelligent lab system.The initial erroneous result was not reported to the physician.The same sample was reprocessed twice with auto dilution and thrice with manual dilution on the original dimension vista 500 intelligent lab system.The reprocessed results obtained were higher and considered erroneous.The same sample was reprocessed with 1:231 manual dilution on the original dimension vista 500 intelligent lab system and a result obtained was higher than the initial result and lower than the other reprocessed results.The reprocessed result with 1:231 manual dilution was considered correct and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneous creatine kinase (cki) results.
Additional Manufacturer Narrative
Additional information (26-mar-2025): siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.Calibration and quality control (qc) recovered within the customer¿s expected ranges, indicating that the creatine kinase (cki) assay was performing acceptably.Siemens requested the return of the sample from the customer for further testing, but it was unavailable with the customer.The cause of the event is unknown.A product problem was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the siemens investigation.Initial mdr 2517506-2025-00017 was filed on 06-feb-2025.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® CREATINE KINASE 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: 21320856
• Report Number: 2517506-2025-00017
• Device Sequence Number: 8129096
• Product Code: CGS
• UDI-Device Identifier: 00842768027925
• UDI-Public: (01)00842768027925(10)24173BB(17)250621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K083465
• 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): 04/16/2025

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: 06/21/2025
• Device Catalogue Number: K2038 SMN 10464356
• Device Lot Number: 24173BB
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2024
• 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