MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 PINK MIMX

Lot Number	5385810
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2023, it was reported that the patient faced a bent cannula when she removed the infusion sets.Due to this issue she felt sick, very weak, her bile threw up and experienced high blood glucose level.Therefore, they tried to treat it via pump, but her blood glucose level was not coming down.So, on (b)(6) 2023, she was admitted to the hospital due to diabetic ketoacidosis with blood glucose level of 500 mg/dl.During hospitalization, the patient received insulin drip intravenously as corrective treatment.After staying for three days in the hospital, the patient was released.Currently, her blood glucose level was 114 mg/dl.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18433836
• Report Number: 3003442380-2024-00105
• Device Sequence Number: 7661060
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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
• Device Expiration Date: 04/01/2025
• Device Lot Number: 5385810
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2023
• Initial Report FDA Received Date: 01/03/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown