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	09/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthcare diagnostics remote services center (rsc) was informed an outside of the united states (ous) customer contacted the local regulatory authority regarding a falsely elevated cardiac troponin i (tni) patient sample result obtained on a dimension exl 200 system.Siemens is investigating the event.
Event or Problem Description
A discordant falsely elevated cardiac troponin i (tni) patient sample result was obtained on a dimension exl 200 system.The falsely elevated result was reported to the physician(s) and the result was questioned.A new sample was drawn from the same patient and processed on the same dimension exl 200 system.A lower tni result, considered correct, was obtained.A corrected report was issued.There are no known reports of patient intervention or adverse health consequences due to the falsely elevated cardiac troponin i (tni) result.
Additional Manufacturer Narrative
Additional information (07-nov-2022): siemens healthcare diagnostics headquarters support center (hsc) concluded the investigation of the event.Hsc reviewed the instrument data logs and the information provided by the customer.Quality control and calibration results were within the customer's expected ranges and no issues were noted with other patient samples.No product non-conformance was identified with the cardiac troponin i (tni) assay or dimension exl 200 system.The cause of the event is unknown.The device is performing within specifications.No further evaluation is required.Section h6 has been updated to reflect the hsc investigation.Initial mdr 2517506-2022-00274 was filed on 14-oct-2022.

• 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: 15605388
• Report Number: 2517506-2022-00274
• Device Sequence Number: 14022995
• Product Code: MMI
• UDI-Device Identifier: 00842768022067
• UDI-Public: 00842768022067
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2022

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: 10/10/2022
• Device Model Number: 10464525
• Device Catalogue Number: RF621 SMN 10464525
• Device Lot Number: FA2283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female