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

Model Number	MMT-397A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced a hyperglycemic episode on (b)(6) 2026, which was successfully managed with self-administered insulin via manual injection, resulting in stable blood glucose levels with no reported complications.
Additional Manufacturer Narrative
E1: (b)(6).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: Quick Set
• 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: 50881769
• Report Number: 3003442380-2026-010633
• Device Sequence Number: 9826063
• Product Code: FPA
• UDI-Device Identifier: 05705244017634
• UDI-Public: 05705244017634
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-397A
• Device Lot Number: 6018057
• 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: 03/01/2026
• 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 Sex: Unknown