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	05/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding two (2) erroneously elevated high-sensitivity troponin i (tnih) results on a patient sample obtained on a dimension vista 1500 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.The instrument data showed that the calibration was acceptable.Quality control (qc) recovery was within the customer¿s expected ranges, and no issues were reported with the other patient samples, indicating that the tnih assay was performing acceptably.There were no dimension vista 1500 system errors.As per the dimension vista tnih instructions for use (ifu), "patient samples may contain heterophilic antibodies or cardiac troponin-specific autoantibodies that could react in immunoassays to give falsely elevated or depressed results.This 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".Hsc concluded that the cause of the event is consistent with a sample-specific issue.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that they obtained two (2) erroneously elevated high-sensitivity troponin i (tnih) results on a patient sample on a dimension vista 1500 system.One of the erroneously elevated results was reported to the physician(s), and the result was not questioned.The patient was sent to an emergency room (er) at another facility, and new samples were drawn from the same patient.The new (redrawn) samples were processed on an alternate non-siemens system.Lower troponin results were obtained, considered correct, and reported.The patient was not admitted when sent to an er at another facility but was kept for several hours to obtain the serial troponin measurements.There are no known reports of adverse health consequences due to the erroneously elevated high-sensitivity troponin i (tnih) results or patient transfer.

• 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: 19623777
• Report Number: 2517506-2024-00175
• Device Sequence Number: 12370694
• 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): 06/27/2024

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: K6427 SMN 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: 06/03/2024
• Initial Report FDA Received Date: 06/27/2024
• 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