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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed loci high-sensitivity troponin i (tnih) result obtained on a patient sample on a dimension exl 200 integrated chemistry system.Siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer and instrument data files.Calibration and quality control (qc) recovered within the customer¿s expected ranges prior to patient sample testing.Siemens reviewed the clot check data and found that the pressure variation was present during the auto-rerun of the initial sample, where the depressed result was obtained.Siemens determined that the probable cause of the event was consistent with the presence of short sample.The customer is operational.The device is performing within specifications.No further evaluation is required.
Event or Problem Description
The customer reported to siemens that they obtained an erroneously depressed loci high-sensitivity troponin i (tnih) result on a patient sample on a dimension exl 200 integrated chemistry system.Initially the sample was processed on the original dimension exl 200 integrated chemistry system and a higher result was obtained considered correct and the result was not reported to the physician(s).The same sample was auto reprocessed on the original dimension exl 200 integrated chemistry system, a lower result was obtained, considered erroneously depressed and reported to the physician(s).A new sample was drawn from the same patient and processed on the original dimension exl 200 integrated chemistry system and a higher result was obtained.The same sample was auto reprocessed on the same dimension exl 200 integrated chemistry system and a higher result was obtained.The new sample results were consistent with the initial result, considered correct and reported to the physician(s).The initial sample was reprocessed again on the original dimension exl 200 integrated chemistry system and a higher result was obtained consistent with new sample results and the initial result, considered correct and reported to the physician(s).The patient was started with anticoagulant therapy based on the erroneously depressed result.There are no known reports of adverse health consequences due to the erroneously depressed loci high-sensitivity troponin i (tnih) result or anticoagulant therapy.

• 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: 22587860
• Report Number: 2517506-2025-00116
• Device Sequence Number: 18476862
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)EA5327(17)251123
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/24/2025

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: 11/23/2025
• Device Model Number: N/A
• Device Catalogue Number: RF627 SMN 10471068
• Device Lot Number: EA5327
• 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: 07/03/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2025
• 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 Sex: Female