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

Model Number	FG000063-04
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient experienced high blood glucose of 380 mg/dl along with large ketone values event with symptoms of fatigue on (b)(6) 2026.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.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: 50912091
• Report Number: 8021545-2026-0061184
• Device Sequence Number: 5393934
• 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): 08/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: FG000063-04
• Device Lot Number: 6017194
• 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: 08/29/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2026
• 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: 41 YR
• Patient Sex: Unknown