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).Event occurred in (b)(6).On (b)(6) 2022, the patient's mother reported that her daughter had a bent cannula last night.Further, she inserted another one and this morning when she woke up, her meter reading was high and when the cannula was removed it was bent (90 degree).Reportedly, she inserted another infusion set (kept the reservoir) did a bolus and it delivered.She went to do a second bolus and got insulin flow block, however, when she removed the cannula, it was straight.The site location was her abdomen and the infusion set had been used for less than a day.Moreover, she did a manual injection.At the time of the incident, her blood glucose level was above 33.3 mmol/l.Currently, her blood glucose level was 18.1 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: 14867461
• Report Number: 3003442380-2022-00798
• Device Sequence Number: 6995359
• 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): 06/30/2022

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 Model Number: MMT-943A600
• Device Lot Number: 5360923
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2022
• Initial Report FDA Received Date: 06/30/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown