MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION LOCI 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	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that an erroneously elevated loci high-sensitivity troponin i (tnih) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.An initial elevated result was obtained on a patient sample.This result was reported to the physician(s) but not questioned.The patient was redrawn twice, and the samples were processed on the original system.Additionally, the first redrawn sample was reprocessed on the original system.The redrawn samples yielded lower results.These lower results were considered correct and reported to the physician(s).A corrected report was issued based on the redrawn sample testing.There are no known reports of patient intervention or adverse health consequences due to the reported event.
Additional Manufacturer Narrative
An outside of the (b)(6) customer contacted a siemens customer care center (ccc) and reported that an erroneously elevated loci high-sensitivity troponin i (tnih) result was obtained on a patient sample on a dimension exl 200 integrated chemistry system.Quality control (qc) recovered within range on the event date.Siemens concluded the investigation of the event.Siemens reviewed the information provided by the customer.No abnormalities were observed with other patient samples, and the issue was isolated to a single sample, indicating no system or reagent-related concerns.The affected sample was no longer available for siemens investigation.Siemens determined that a sample specific interference potentially contributed to the reported event.The customer is operational.The device is performing within specifications.No further evaluation is required.

• Brand Name: DIMENSION
• Common Device Name: DIMENSION LOCI 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: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 23887734
• Report Number: 2517506-2025-00185
• Device Sequence Number: 11930079
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FB6125(17)260505
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 12/24/2025

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: 05/05/2026
• Device Model Number: N/A
• Device Catalogue Number: 10471068
• Device Lot Number: FB6125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/09/2025
• 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: 84 YR
• Patient Sex: Male