MAUDE Adverse Event Report: UNOMEDICAL A/S INSET GUARD; UNO MIO ADV. GREY 60/6 SC1 10-PK INT

Model Number	MMT-242A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Refrence number (b)(4).Event occured in the united states.It was reported that the patient was hospitalized due to low blood glucose (52 mg/dl) on (b)(6) 2026.The patient received treatment with aktose during the hospitalization.The duration of hospitalization was less than 24 hours.No further information is available.

• Brand Name: INSET GUARD
• Common Device Name: UNO MIO ADV. GREY 60/6 SC1 10-PK INT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, denmark 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, denmark 4320
• MDR Report Key: 24738633
• Report Number: 8021545-2026-02992
• Device Sequence Number: 9839863
• Product Code: FPA
• UDI-Device Identifier: 05705244018877
• UDI-Public: 05705244018877
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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-242A
• Device Lot Number: 6016035
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2025
• 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