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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed result with loci high-sensitivity troponin i (tnih) on one patient sample on a dimension exl with lm integrated chemistry system.Siemens is investigating the event.
Event or Problem Description
The customer reported to siemens they obtained an erroneously depressed loci high-sensitivity troponin i (tnih) result on one (1) patient sample on a dimension exl with lm integrated chemistry system.The erroneously depressed result was not reported to the physician.The initial result for the same sample, obtained on the original dimension exl with lm integrated chemistry system, was a higher result, which was considered correct and not reported to the physician.Following the erroneously depressed result, the same sample was reprocessed two more times on the original dimension exl with lm integrated chemistry system.Higher results were obtained, considered correct, and reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed loci high-sensitivity troponin i (tnih) result.
Additional Manufacturer Narrative
Additional information (09-may-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.No reagent or instrument issues were identified.The cause of the event is unknown.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 2517506-2025-00073 was filed on 07-may-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: 21976943
• Report Number: 2517506-2025-00073
• Device Sequence Number: 9197897
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)EA5245(17)250902
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: 09/02/2025
• Device Model Number: N/A
• Device Catalogue Number: 10471068
• Device Lot Number: EA5245
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• 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