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

Model Number	1001682
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient faced infusion set tubing was leaking at the site issue on (b)(6) 2025.The patient experienced high blood glucose levels and event was resolved by correction bolus via pump.
Additional Manufacturer Narrative
Mdr 3003442380-2026-67442 / initial 4 of 4.Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a capa 2356421 and capa 2566479 in accordance with the fda action plan, which incorporates (b)(4) (ic retrospective complaint review) and (b)(4) (ic retrospective mdr review).This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this initial information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged.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: 3003442380.

• Brand Name: Inset
• 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: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50151881
• Report Number: 3003442380-2026-67442
• Device Sequence Number: 9341605
• Product Code: FPA
• UDI-Device Identifier: 05705244016682
• UDI-Public: 05705244016682
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• 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): 07/08/2026

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: 1001682
• Device Lot Number: 6010097
• 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: 07/08/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2024
• 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: 48 YR
• Patient Sex: Female