MAUDE Adverse Event Report: UNOMEDICAL A/S iLet Flex; Set, Administration, Intravascular

Model Number	FG000063-04
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the infusion set required replacement because the tubing became detached from the patient's body while the connector remained intact in the pump on (b)(6)2026.
Additional Manufacturer Narrative
Imdrf investigation findings code: code c1902 is not available in database to capture device problem excluded.Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions and health impact.H11: investigation summary.Complaint investigation results.A complaint investigation was performed based on the event description and the assigned malfunction code connection/adhesive issues- accidental - not infusion set related.Lot number was provided; however, the evaluation of the event description did not identify evidence of device malfunction or product-related failure.Based on the information available, the complaint is consistent with scenarios involving misuse, user-related factors, or no malfunction alleged, as reflected in the assigned malfunction code.In accordance with appendix work instruction (wi) complaint handling, the need for additional investigation activities, including batch record review, product testing, or electronic quality management system (eqms) search, was evaluated and determined not to be warranted for this record.Corrective and preventive action (capa) determination - conclusion: based on the investigation, no further action is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).Root cause of problem: n/a - no further root cause investigation is required as the complaint does not allege a product malfunction.Corrective action as a result of the investigation: n/a - as no root cause investigation was required, no capa plan is applicable.The record will be closed with no further actions.Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Reporting site: 8021545.Manufacturing site: 8021545.

• Brand Name: iLet Flex
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320
• Manufacturer (Section G): UNOMEDICAL A/S; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320
• Manufacturer Contact: armando cuello ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50929057
• Report Number: 8021545-2026-0060464
• Device Sequence Number: 13445413
• Product Code: FPA
• UDI-Device Identifier: 05705244026889
• UDI-Public: 05705244026889
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K173879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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: Lay User/Patient
• Device Model Number: FG000063-04
• Device Lot Number: 6016558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Unknown