MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 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	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to siemens they obtained an erroneously elevated loci high-sensitivity troponin i (tnih) result on a patient sample on the dimension exl 200 integrated chemistry system.The initial erroneously elevated result was reported to the physician and questioned.The same sample was reprocessed on the same dimension exl 200 integrated chemistry system.A lower result was obtained and considered correct.The same sample was reprocessed on two alternate dimension exl 200 integrated chemistry systems.Lower results were obtained and considered correct.A second sample for the same patient was processed on the same dimension exl 200 integrated chemistry system.A lower result was obtained and considered correct.Both samples from the same patient were reprocessed on alternate dimension exl 200 integrated chemistry systems.Lower results were obtained and considered correct.There are no known reports of adverse health consequences due to the erroneously elevated loci high sensitivity troponin i (tnih) result.
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated loci high-sensitivity troponin i (tnih) result on a patient sample on the dimension exl 200 integrated chemistry system.Siemens is investigating the event.
Additional Manufacturer Narrative
Additional information (19-may-2025): siemens service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer and the data from the instrument.No reagent or instrument issues were identified.Quality control (qc) recovered within the customer¿s acceptable ranges.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.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2517506-2025-00078 was filed on 15-may-2025.

• Brand Name: DIMENSION EXL 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: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 22030538
• Report Number: 2517506-2025-00078
• Device Sequence Number: 8492804
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)EA5272(17)250929
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 09/29/2025
• Device Model Number: N/A
• Device Catalogue Number: 10471068
• Device Lot Number: EA5272
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• 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 Age: 19 YR
• Patient Sex: Male