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

Catalog Number	RF627 SMN 10471068
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
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 with lm integrated chemistry system.Siemens healthcare diagnostics concluded the investigation of the event.Siemens reviewed the information provided by the customer.Calibration and quality control (qc) recovered within the customer¿s expected ranges.A siemens customer service engineer (cse) was dispatched to the customer's site.During the visit, the cse performed a preventive maintenance (pm), including all alignments and found that the loci statistics were acceptable.The cause of the event is unknown.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 with lm integrated chemistry system.The erroneous result was reported to the physician and was questioned.The same sample was reprocessed on the same dimension exl with lm integrated chemistry system and a higher result was obtained.The higher reprocessed result was considered correct and reported to the physician.Two new samples were drawn from the same patient and processed at different times during patient admission for correlation study purposes, the results obtained were higher and considered correct.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed loci high-sensitivity troponin i (tnih) result.

• 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: mekala g ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 840457474
• MDR Report Key: 21250472
• Report Number: 2517506-2025-00015
• Device Sequence Number: 8056292
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FA5173(17)250622
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 01/28/2025

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: 06/22/2025
• Device Catalogue Number: RF627 SMN 10471068
• Device Lot Number: FA5173
• 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: 01/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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: 70 YR
• Patient Sex: Female