MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION; DIMENSION LOCI HIGH-SENSITIVITY TROPONIN I FLEX REAGENT CARTRIDGE

Catalog Number	10471068
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding erroneous loci high-sensitivity troponin i (tnih) results obtained on a patient sample on a dimension exl with lm integrated chemistry system.Quality control (qc) was acceptable on the day of the event.Siemens reviewed the available instrument data, and the information provided by the customer.The customer confirmed that the initial dilutions were performed using reagent-grade water instead of the cardiac troponin i (ctni) sample diluent as recommended in the assay¿s instructions for use (ifu).Upon repeating the dilution with the correct diluent, the expected result was obtained.Siemens evaluated the event and determined that the use of an incorrect diluent potentially contributed to the erroneous tnih result(s).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 erroneous loci high-sensitivity troponin i (tnih) results were obtained on a patient sample on a dimension exl with lm integrated chemistry system.An initial low result with an ¿assay range¿ flag was obtained.The sample was diluted and reprocessed twice on the original system using reagent-grade water.The reprocessed results were higher than the initial result and had no flags.One of these higher reprocessed results was reported to the physician(s), who questioned the result.After two days, the sample was reprocessed three times on the original system; two of these reprocessed results recovered low with an ¿assay range¿ flag and matched the initial result.The other reprocessed result was lower than the erroneous results with no flag.The lower reprocessed result with no flag was reported as the correct result to the physician(s).There are no known reports of patient interventions or adverse health consequences due to the erroneous loci high-sensitivity troponin i (tnih) results.

• 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: 23551830
• Report Number: 2517506-2025-00171
• Device Sequence Number: 9322610
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FA6102(17)260412
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 11/14/2025

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: 04/12/2026
• Device Catalogue Number: 10471068
• Device Lot Number: FA6102
• 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: 10/20/2025
• Initial Report FDA Received Date: 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2025
• 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: 50 YR
• Patient Sex: Female