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	Hyperglycemia (1905)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in canada.On 28-sep-2021, the patient's mother reported that her son was getting insulin flow block alarm during bolus, and he got it with previous infusion set as well.Therefore, his blood glucose level was 30 mmol/l at the time of the event.Recently, she changed everything (2 minutes ago) and was still getting insulin flow block alarm.Moreover, the site location was patient's buttock.Reportedly, the patient's infusion set cannula was bent.Currently, his blood glucose level was 12.8 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: 16330948
• Report Number: 3003442380-2023-00150
• Device Sequence Number: 6817686
• 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): 02/09/2023

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: 12/01/2023
• Device Model Number: MMT-943A600
• Device Lot Number: 5341383
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/09/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown