MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. 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	12/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states reported observation of an elevated high-sensitivity troponin i (tnih) which was discordant relative to repeat testing at an alternate hospital.Siemens reviewed the instrument data and the information provided by the customer.Reagent and instrument related issues were ruled out based on quality control (qc) results recovering within acceptable ranges, valid calibration, and proficiency testing for tnih on the analyzer met acceptance criteria.A customer service engineer (cse) visited the customer¿s site and performed preventive maintenance (pm) on the analyzer.Return of the patient sample for further investigation was not warranted as the discordant result was not reproducible.Based on the available information, the cause of the discordant elevated result was consistent with a sample specific interferent and the issue was isolated to the affected patient sample.The issue was resolved by routine troubleshooting; a product problem was not identified.Customer is operational and no further actions are required.
Event or Problem Description
The customer reported observation of an elevated high-sensitivity troponin i (tnih) which was discordant relative to repeat testing at an alternate hospital when using lot fb6082.An initial elevated result was obtained for the patient in question.The initial elevated result was reported to the physician.Based on this result, the physician referred the patient to an alternate hospital approximately 3 to 4 hours away due to concern for a possible cardiac event.At the alternate hospital, a new sample was collected and tested using an unknown methodology, which yielded a lower result.The lower result was considered correct since it recovered within the normal range and was reported to the physician.There are no allegations of patient harm or adverse health consequences due to the reported event.

• Brand Name: DIMENSION
• Common Device Name: 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: 24018579
• Report Number: 2517506-2026-00005
• Device Sequence Number: 18780322
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FB6082(17)260323
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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: 03/23/2026
• Device Model Number: N/A
• Device Catalogue Number: 10471068
• Device Lot Number: FB6082
• 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: 12/16/2025
• Initial Report FDA Received Date: 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2025
• 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: 83 YR
• Patient Sex: Male