MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION® LOCI HIGH-SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

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	05/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding an erroneously elevated loci high-sensitivity troponin i (tnih) result obtained on one patient on a dimension exl 200 integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens they obtained an erroneously elevated loci high-sensitivity troponin i (tnih) result on one (1) patient sample on a dimension exl 200 integrated chemistry system.The erroneously elevated result was reported to the physician and questioned.The initial result for the same sample, obtained on the original dimension exl 200 integrated chemistry system, was a lower result, which was considered correct and not reported to the physician.Following the erroneously elevated result, the same sample was reprocessed on the original dimension exl 200 integrated chemistry system.A lower result was obtained, considered correct, and not reported to the physician.A new sample from the same patient was drawn and processed twice on the original dimension exl 200 integrated chemistry system.Lower results were obtained and considered correct.One of the re-drawn results was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously elevated loci high-sensitivity troponin i (tnih) result.
Additional Manufacturer Narrative
Additional information (05-jun-2025): siemens healthcare diagnostics service operations support (sos) concluded the investigation of the event.Sos evaluated the information provided by the customer and the available instrument data.Quality control (qc) recovery was within the customer¿s acceptable ranges.The customer diluted the sample using distilled water instead of using ctni sample diluent (ctni dil) as directed in the instructions for use (ifu).The cause of the issue was consistent with use error, where the distilled water was used to dilute the patient sample instead of ctni diluent.The customer stated the issue was resolved when using the ctni diluent and no other discordant results were reported.The customer is operational.The device is performing within specifications.A potential product issue was not identified.No further evaluation is required.Section h6 has been updated to reflect the sos investigation.Initial mdr 2517506-2025-00087 was filed on 02-jun-2025.

• Brand Name: DIMENSION® LOCI HIGH-SENSITIVITY TROPONIN I FLEX® REAGENT CARTRIDGE
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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: 22127119
• Report Number: 2517506-2025-00087
• Device Sequence Number: 8906877
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)EA5236(17)250824
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K190675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2025

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: 08/24/2025
• Device Model Number: N/A
• Device Catalogue Number: 10471068
• Device Lot Number: EA5236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/28/2024
• 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: Male