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	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding two (2) falsely elevated high-sensitivity troponin i (tnih) results obtained on a patient sample on two (2) dimension vista 500 systems.Siemens is investigating the event.
Event or Problem Description
Two (2) discordant falsely elevated high-sensitivity troponin i (tnih) results were obtained on a patient sample on two (2) dimension vista 500 systems.The falsely elevated results were reported to the physician(s), and the results were questioned.The same sample was reprocessed on an alternate non-siemens system using troponin i methodology.A lower result, considered correct, was obtained.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated high-sensitivity troponin i (tnih) results.
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 confirmed the presence of an interferent consistent with macro troponin.The cause of the event was determined to be the presence of macro troponin interference.A potential product issue was not identified.The customer is operational.The dimension vista tnih instructions for use (ifu) states, ¿patient samples may contain cardiac troponin-specific autoantibodies that could react in immunoassays to give elevated or depressed results.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution.Samples from patients receiving preparations of mouse monoclonal antibodies for therapy or diagnosis may contain human anti-mouse antibodies (hama).Such samples may show either falsely elevated or falsely depressed values.The tnih assay has been designed to minimize interference from heterophilic antibodies.Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed.A test result that is inconsistent with the clinical picture and patient history should be interpreted with caution.¿ initial mdr 2432235-2023-00165 was filed on 16-jun-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: 17144329
• Report Number: 2432235-2023-00165
• Device Sequence Number: 12157114
• 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: 05/23/2023
• 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