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

Lot Number	5360889
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 (b)(6).On (b)(6) 2022, the patient's parent reported that their daughter had high blood glucose levels for three days now, due to a bent cannula which they tried to treat with a pump and manual injection.The infusion set was changed on (b)(6) 2022.At the time of the event ((b)(6) 2022), her blood glucose level was 20 mmol/l.Consequently, on (b)(6) 2022 at 1:00 am, she was admitted to the hospital as she experienced vomiting, abdominal pain, and positive results in ketones test (3 mmol/l).She was admitted in the hospital for three days.Currently, her blood glucose level was 26 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 46/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14332609
• Report Number: 3003442380-2022-00605
• Device Sequence Number: 17706225
• 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): 05/09/2022

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: 08/01/2024
• Device Lot Number: 5360889
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/08/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown