MAUDE Adverse Event Report: UNOMEDICAL A/S INSET GUARD; EWIS BLUE 60/6 HCAP 4-PACK

Model Number	MMT-431AK
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/28/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: patient city - (b)(6).Patient country - australia.
Event or Problem Description
Reference number (b)(4).Event occurred in australia.It was reported that the patient faced hyperglycemia on (b)(6) 2026.The blood glucose level was high and the patient was treated with manual bolus.No further information available.

• Brand Name: INSET GUARD
• Common Device Name: EWIS BLUE 60/6 HCAP 4-PACK
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1 - 3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1 - 3; osted; lejre, 4320
• MDR Report Key: 24740272
• Report Number: 8021545-2026-02645
• Device Sequence Number: 8859273
• Product Code: FPA
• UDI-Device Identifier: 05705244025370
• UDI-Public: 05705244025370
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/01/2026

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-431AK
• Device Lot Number: 6015884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown