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

Model Number	10471067
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Two (2) elevated high-sensitivity troponin i (tnih) results were obtained on a patient sample on two (2) dimension vista 500 systems.The elevated results were reported to the physician(s), and the results were questioned.Subsequently, the customer determined that the results were falsely elevated.However, the sample was not reprocessed further, and the customer stated that no correct result was obtained or reported.There are no known reports of patient intervention or adverse health consequences due to the elevated high-sensitivity troponin i (tnih) results.
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding two (2) elevated high-sensitivity troponin i (tnih) results obtained on a patient sample on two (2) dimension vista 500 systems.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (22-jun-2023): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data logs and the information provided by the customer.Hsc requested that the customer send the patient sample to siemens healthineers for internal investigation.Hsc received the patient sample from the customer and performed an evaluation for an autoantibody/immune-complex interference (macro troponin) with the high-sensitivity troponin i (tnih) assay.Quality control and calibration results were within the customer's expected ranges, indicating that the two (2) dimension vista 500 systems were performing acceptably.The siemens internal investigation ruled out the presence of an interferent consistent with macro troponin.However, there was insufficient sample available for additional studies to rule out other types of patient-specific antibody interferences.The cause of the event is unknown.A potential product issue 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 hsc investigation.Initial mdr 2432235-2023-00166 was filed on (b)(6) 2023.

• 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: 17144335
• Report Number: 2432235-2023-00166
• Device Sequence Number: 20269854
• Product Code: MMI
• UDI-Device Identifier: 00842768037719
• UDI-Public: 00842768037719
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/17/2023

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: 12/17/2023
• Device Model Number: 10471067
• Device Catalogue Number: K6427 SMN 10471067
• Device Lot Number: 23051AA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2023
• 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 Sex: Unknown