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	09/10/2024
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 system.Siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data files and the information provided by the customer.Calibration was acceptable, and the system check was within specifications.Quality control (qc) recovered within the customer¿s expected ranges and no issues were reported with the other patient samples.The issue was resolved by reprocessing the same sample on the original dimension exl with lm system.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.
Event or Problem Description
The customer reported to siemens they obtained an erroneously depressed loci high-sensitivity troponin i (tnih) result on a patient sample on a dimension exl with lm system.The erroneously depressed result was reported to the physician, and the result was not questioned.The same sample was reprocessed on the original dimension exl with lm system.A higher reprocessed result was obtained, which matched the patient's clinical picture and was 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.

• 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: 20308940
• Report Number: 2517506-2024-00237
• Device Sequence Number: 7745339
• Product Code: MMI
• UDI-Device Identifier: 00842768037726
• UDI-Public: (01)00842768037726(10)FB5104(17)250414
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/26/2024

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: 04/14/2025
• Device Model Number: N/A
• Device Catalogue Number: RF627 SMN 10471068
• Device Lot Number: FB5104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2024
• 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: 54 YR
• Patient Sex: Male