MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 PINK MIMX

Lot Number	5382726
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) 2022, it was reported that the patient faced a bad site last week and had to use extra sets to make sure it was working right.Earlier, this week, the patient experienced 2 bent cannulas due to which the patient experienced high blood glucose level, felt sick/unwell, dehydrated and vomiting.Therefore, on (b)(6) 2022, the patient was hospitalized due to diabetic ketoacidosis with blood glucose level of 412 mg/dl.Moreover, the test for ketones was confirmed and ketones were present.The infusion set was changed on the morning of hospitalization.Further, the patient was transferred to the intensive care unit during which the infusion sets were changed 4 times.During hospitalization, the patient received intravenous insulin drip as corrective treatment.The patient spent three days in the hospital.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 available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15678438
• Report Number: 3003442380-2022-01082
• Device Sequence Number: 2415101
• Product Code: FPA
• UDI-Device Identifier: 05705244019911
• UDI-Public: 05705244019911
• Combination Product (Y/N): Y
• 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): 10/27/2022

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: 03/01/2025
• Device Lot Number: 5382726
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 10/27/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown