MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; HIGH SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE

Model Number	N/A
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding a falsely elevated patient result with high-sensitivity troponin i (tnih) obtained on a dimension vista 500 system.Siemens concluded the investigation of the event.Siemens investigation included an assessment of reagent, instrument, and sample data.Quality control and calibration results were within the customer's expected ranges on the event date.Siemens cannot rule out the sample integrity issues.The issue was resolved by repeating the sample on the same analyzer.Return of patient sample for further evaluation is not warranted as the repeated result is acceptable.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing according to specifications.No further evaluation is required.
Event or Problem Description
A discordant falsely elevated high-sensitivity troponin i (tnih) patient sample result was obtained on a dimension vista 500 system.The falsely elevated result was reported to the physician(s), and the result was questioned.The same sample was reprocessed on the original dimension vista 500 system.Additionally, two new samples were drawn from the same patient and processed on the original dimension vista 500 system.The reprocessed results and the new (redrawn) sample results obtained were lower and considered correct.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated patient result with high-sensitivity troponin i (tnih).

• Brand Name: DIMENSION VISTA®
• Common Device Name: HIGH SENSITIVITY TROPONIN I 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: 18902991
• Report Number: 2517506-2024-00098
• Device Sequence Number: 9256268
• Product Code: MMI
• UDI-Device Identifier: 00842768037719
• UDI-Public: 00842768037719
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K182225
• 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): 03/14/2024

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: 10/13/2024
• Device Model Number: N/A
• Device Catalogue Number: SMN 10471067
• Device Lot Number: 23352BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2023
• 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 Age: 19 YR
• Patient Sex: Female