MAUDE Adverse Event Report: MIO; UNO INSET II 80/6 SC1 GREY MCAN

Model Number	MMT-965A600
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).Report source foreign: (b)(6).On (b)(6) 2022, the patient's father reported that the patient faced a bent cannula issue while sitting.In the morning of (b)(6) 2022, the infusion set was last changed, and the high blood glucose event also occurred the same day.The site location was the patient's lower back and the infusion set had been used for a few hours.At the time of the incident, the patient's blood glucose level was 36.6 mmol/l.Consequently, in the morning of (b)(6) 2022, the patient was admitted to the hospital with high blood glucose level of 36.6 mmol/l, ketones, and diabetic ketoacidosis.During hospitalization, the patient was administered some unspecified medication (drug name unknown) intravenously.Moreover, the patient was hospitalized for two days.Currently, the patient's blood glucose level was 11 mmol/l.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 80/6 SC1 GREY MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14389464
• Report Number: 3003442380-2022-00643
• Device Sequence Number: 5149263
• Product Code: FPA
• UDI-Device Identifier: 05705244020399
• UDI-Public: 05705244020399
• 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): 05/13/2022

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: 03/01/2023
• Device Model Number: MMT-965A600
• Device Lot Number: 5313464
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2022
• Initial Report FDA Received Date: 05/13/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown