MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION®; CARDIAC TROPONIN I FLEX® REAGENT CARTRIDGE

Model Number	10464525
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elevated cardiac troponin i (tni) quality control (qc) sample results were obtained on a dimension exl 200 system.The elevated tni qc results were above the laboratory acceptance range.The customer stated that tni patient sample result reporting was delayed.The duration of the delay was not provided.There are no known reports of patient intervention or adverse health consequences due to the out of acceptance range tni quality control results or the delay in patient sample result reporting.
Additional Manufacturer Narrative
The united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding elevated cardiac troponin i (tni) quality control sample results obtained on dimension exl system.The customer stated that patient sample result reporting was delayed.The duration of delay was not provided.Siemens is investigating the event.
Additional Manufacturer Narrative
The united states customer contacted the siemens healthcare diagnostics customer care center (ccc) regarding elevated cardiac troponin i (tni) quality control sample results obtained on dimension exl system.The customer stated that patient sample result reporting was delayed.The duration of delay was not provided.Siemens is investigating the event.
Event or Problem Description
Elevated cardiac troponin i (tni) quality control (qc) sample results were obtained on a dimension exl 200 system.The elevated tni qc results were above the laboratory acceptance range.The customer stated that tni patient sample result reporting was delayed.The duration of the delay was not provided.There are no known reports of patient intervention or adverse health consequences due to the out of acceptance range tni quality control results or the delay in patient sample result reporting.
Additional Manufacturer Narrative
Additional information (16-dec-2021) - siemens headquarters support center (hsc) has completed the evaluation of the event.Hsc has reviewed the instrument data and the information provided by the customer.Hsc concluded that a product non-conformance was not identified with the cardiac troponin i (tni) assay or the dimension exl 200 system.The customer reported quality control (qc) recovering out of laboratory acceptance limits on the dimension exl cardiac troponin i (tni) assay.The unacceptable qc results occurred with a single vial of non-siemens third-party qc material.No patients results or other qc results were affected.Reprocessing the qc using a new vial of quality control material resolved the issue.The cause of the event is unknown.The customer is operational.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2021-00345 was filed on 16-dec-2021.

• Brand Name: DIMENSION®
• Common Device Name: CARDIAC 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: james morgera ; 500 gbc drive; po box 6101; newark, DE 19714-6101
• MDR Report Key: 13019585
• Report Number: 2517506-2021-00345
• Device Sequence Number: 11947378
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K081643
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2022

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: 06/13/2022
• Device Model Number: 10464525
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: EA2164
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 12/16/2021
• Supplement Report FDA Received Date: 01/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown