MAUDE Adverse Event Report: MIO; UNO INSET II 80/9 SC1 GREY MCAN

Model Number	MMT-975A600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in (b)(6).On (b)(6) 2021, the patient reported the infusion set's tubing detached close to the site location.This issue occurred with four sets.The site location was the patient's buttocks.The infusion had been used for a day or less.He kept his supply in a drawer in the washroom.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.No further information available.
Event or Problem Description
On 09-jul-2021: follow up information was submitted because reference samples were visually inspected and tested for static pull to tubing connector.Therefore, all test results were within specifications.Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2021, the patient reported the infusion set's tubing detached close to the site location.This issue occurred with four sets.The site location was the patient's buttocks.The infusion had been used for a day or less.He kept his supply in a drawer in the washroom.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 SC1 GREY MCAN
• MDR Report Key: 12106195
• Report Number: 3003442380-2021-00308
• Device Sequence Number: 11807185
• Product Code: FPA
• UDI-Device Identifier: 05705244020429
• UDI-Public: 05705244020429
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: MMT-975A600
• Device Lot Number: 5341384
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 07/09/2021
• Patient Sequence Number: 1