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

Model Number	FG000063-04
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Premature Separation (4045)
Health Effect - Clinical Codes	Hyperglycemia (1905); Diaphoresis (2452)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported that the infusion set is coming off after taking shower which lead to hyperglycaemia and diaphoresis on (b)(6) 2026.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number 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: 50877701
• Report Number: 8021545-2026-0059017
• Device Sequence Number: 10674286
• 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
• Report Date (Section B): 08/26/2026

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: 6017720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2026
• 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: 69 YR
• Patient Sex: Unknown