MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL LOCI HIGH SENSITIVITY TROPONIN I (TNIH) ASSAY; IMMUNOASSAY METHOD, TROPONIN SUBUNIT

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	12/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously elevated loci high-sensitivity troponin i (tnih) patient sample result on a dimension exl 200 integrated chemistry system.Siemens healthcare diagnostics is investigating the event.
Event or Problem Description
The customer reported to siemens they obtained one (1) erroneously elevated loci high-sensitivity troponin i (tnih) result on a patient sample on a dimension exl 200 integrated chemistry system.The erroneously elevated result was reported to the physician and questioned.The same sample was reprocessed on a quick test (method unknown).Negative result obtained, considered correct, and reported to the physician.The patient was admitted to the hospital for a half day and discharged without diagnosis.The patient was not treated due to the tnih erroneously elevated result.There are no known reports of adverse health consequences due to the erroneously elevated loci high sensitivity troponin i (tnih) result.
Additional Manufacturer Narrative
Additional information (26-jan-2025): siemens service operations support (sos) concluded the investigation of the event.Sos reviewed the information provided by the customer and the data from the instrument.No reagent or instrument issues were identified.Quality control (qc) recovered within the customer¿s laboratory ranges at the time of the event.Siemens does not have claims on correlation with other analyzers which use an alternate methodology and antibodies for troponin analyte measurement.As the technology used by analyzers were different, there should not be any numerical comparison between the analyzers.The cause of the event is unknown.A potential product issue was not identified.The customer is operational.The device is performing within specifications.No further evaluation is required.In section h6, the investigation finding and investigation conclusion codes were updated.Initial mdr 2517506-2025-00009 was filed on 23-jan-2025.

• Brand Name: DIMENSION EXL LOCI HIGH SENSITIVITY TROPONIN I (TNIH) ASSAY
• Common Device Name: IMMUNOASSAY METHOD, TROPONIN SUBUNIT
• 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: eiman sulieman ; 500 gbc drive; po box 6101; newark, DE 19714-6101 ; 7372808688
• MDR Report Key: 21218025
• Report Number: 2517506-2025-00009
• Device Sequence Number: 3517946
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)EA5159(17)250608
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K190675
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 06/08/2025
• Device Model Number: N/A
• Device Catalogue Number: 10471068
• Device Lot Number: EA5159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• 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 Sex: Unknown