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	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer from the united states reported observation of an elevated dimension exl high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing.Siemens reviewed the instrument data and the information provided by the customer.Temperature checks and contamination readings were within acceptable limits.Reagent and instrument related issues were ruled out based on quality control (qc) recovery within acceptable ranges and no issues were reported with other patient samples.Return of the patient sample for further investigation was not warranted because discordant result was not reproducible.Based on the available information, the cause of the discordant result was consistent with a hemolytic interference, as the initial sample was noted to be moderately hemolyzed.The redrawn sample showed no evidence of hemolysis and generated the expected result.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 reports observation of an elevated dimension exl high-sensitivity troponin i (tnih) result which was discordant relative to repeat testing when using lot fc6102.An initial elevated result was obtained for the patient in question.The initial elevated result was reported to the physician who questioned the result.The patient was redrawn after one hour, and the redrawn sample was retested on the same system, yielding a lower result.Both the initial and redrawn samples were subsequently retested on the original system and on an alternate system, producing lower results consistent with the redrawn sample result.The lower result was considered correct, and a corrected report was issued to the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis or treatment resulting from the observed result discordance.

• 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: 24343045
• Report Number: 2517506-2026-00040
• Device Sequence Number: 18560610
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FC6102(17)260412
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/16/2026

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: 04/12/2026
• Device Model Number: N/A
• Device Catalogue Number: 10471068
• Device Lot Number: FC6102
• 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: 01/21/2026
• Initial Report FDA Received Date: 02/16/2026
• 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 Sex: Female