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	07/30/2024
Type of Reportable Event	Malfunction
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 system.The erroneously depressed result was reported to the physician(s), and the result was questioned.The same sample was reprocessed on the original dimension exl system twice.Higher reprocessed results were obtained and considered correct.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the erroneously depressed loci high sensitivity troponin i (tnih) result.
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens healthcare diagnostics remote services center (rsc) regarding an erroneously depressed loci high sensitivity troponin i (tnih) result on a patient sample obtained on a dimension exl system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the available instrument data files and the information provided by the customer.Quality control (qc) recovery was within the customer¿s expected ranges, and no issues were reported with the other patient samples, indicating that the tnih assay was performing acceptably.Calibration and system check were acceptable.There were no dimension exl system errors observed, and the issue was resolved by reprocessing the same sample on the original dimension exl system.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.

• 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: linda barletta ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 20002529
• Report Number: 2517506-2024-00213
• Device Sequence Number: 20072045
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FB4350(17)241215
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/16/2024

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: 12/15/2024
• Device Model Number: N/A
• Device Catalogue Number: RF627 SMN 10471068
• Device Lot Number: FB4350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2024
• 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: 76 YR
• Patient Sex: Female