MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA®; 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	05/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens that they obtained an erroneously elevated high-sensitivity troponin i (tnih) patient sample result on the dimension vista 1500 system.The erroneous result was reported to the physician and was questioned.The same sample was reprocessed on the original dimension vista 1500 system and on an alternate dimension vista 1500 system and lower results were obtained.A new sample was drawn from the same patient and processed on the original system and the result recovered lower.The customer also reprocessed on an alternate dimension vista 1500 system and did not provide the result.The result of 6.3 pg/ml from the newly drawn sample was reported as the correct result to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated high-sensitivity troponin i (tnih) result on a patient sample.
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens remote services center (rsc) regarding an erroneously elevated high-sensitivity troponin i (tnih) result obtained on a patient sample on the dimension vista 1500 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the information provided by the customer and the instrument data files.Calibration and quality control were within the customer's expected ranges.Customer replaced reagent flex with a new reagent flex of same lot and processed quality controls which recovered within the customer's expected ranges.The customer performed a patient comparison study using 2 analyzers and 10 patient samples.All samples recovered within the customer's expected ranges.No other patient samples were reported discordant by the customer.The cause of the event is unknown.The customer is fully operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION VISTA®
• Common Device Name: DIMENSION VISTA® 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: 19518392
• Report Number: 2517506-2024-00164
• Device Sequence Number: 17649883
• Product Code: MMI
• UDI-Device Identifier: 00842768037719
• UDI-Public: 00842768037719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 06/12/2024

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: 12/04/2024
• Device Model Number: N/A
• Device Catalogue Number: 10471067
• Device Lot Number: 24039BA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2024
• 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