MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 BLUE MCAN

Model Number	MMT-943A600
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).Foreign: (b)(6).On (b)(6) 2022, the patient's mother reported that the patient experienced high blood glucose levels due to a bent cannula.The site location was the patient's abdomen.At the time of the incident the patient's blood glucose level was more than 33 mmol/l and the infusion set was changed on (b)(6) 2022 (in the morning).Subsequently, in the night of (b)(6) 2022, the patient was admitted to the hospital with blood glucose level of more than 33 mmol/l and ketones, and diabetic ketoacidosis.During hospitalization, the patient received some unspecified medication (drug name unknown) intravenously as corrective treatment.Further, the patient was admitted in the hospital overnight.At the time of this report (currently), the patient's blood glucose level was 16.3 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 60/6 SC1 BLUE MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14139612
• Report Number: 3003442380-2022-00559
• Device Sequence Number: 17714929
• Product Code: FPA
• UDI-Device Identifier: 05705244020337
• UDI-Public: 05705244020337
• 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): 04/19/2022

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: 06/01/2024
• Device Model Number: MMT-943A600
• Device Lot Number: 5355968
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/19/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown