MAUDE Adverse Event Report: MIO®; UNO INSET II 46/6 PCC PINK MCAN

Model Number	MMT-921600
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that on (b)(6) 2021, the patient's infusion set's tubing detached from where the tubing starts, when she was going to insert it, but then inserted another infusion set.The site location was her leg, and the pump was located on her hip.The infusions were stored in a cupboard.There was not stress or pull on the tubing and the pump was not dropped with the set connected to their body.Reportedly, the patient's blood glucose level was 13.6 mmol/l.No further information available.
Event or Problem Description
On 16-nov-2021: follow up information was submitted to update the awareness date and the result of complaint investigation of the returned used device (1 set) showed that all the test results were within specification.Based on the result: medical device problem code, component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in canada.It was reported that on (b)(6) 2021, the patient's infusion set's tubing detached from where the tubing starts, when she was going to insert it, but then inserted another infusion set.The site location was her leg, and the pump was located on her hip.The infusions were stored in a cupboard.There was not stress or pull on the tubing and the pump was not dropped with the set connected to their body.Reportedly, the patient's blood glucose level was 13.6 mmol/l.No further information available.

• Brand Name: MIO®
• Common Device Name: UNO INSET II 46/6 PCC PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12408639
• Report Number: 3003442380-2021-00421
• Device Sequence Number: 5002948
• Product Code: FPA
• UDI-Device Identifier: 05705244007390
• UDI-Public: 05705244007390
• 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
• Report Date (Section B): 11/16/2021

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
• Device Expiration Date: 11/01/2022
• Device Model Number: MMT-921600
• Device Lot Number: 5278610
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown