MAUDE Adverse Event Report: MIO®; UNO INSET II 80/6 PCC GREY MIMX

Model Number	MMT-965
Medical Device Problem Codes	Detachment of Device or Device Component (2907); No Apparent Adverse Event (3189)
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 the united states.On (b)(6) 2021, it was reported that the patient's infusion set's tubing had disconnected at the site while inserting the set.The site location was her abdomen, and the pump was not used yet.The infusion sets were stored in a closet.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, her blood glucose level was 134 mg/dl.No further information available.
Event or Problem Description
On (b)(6) 2022: follow up information was submitted to add date of this report and to update the awareness date.Moreover, the result of complaint investigation of returned used device (one introducer needle), showed that the visual test result was within specifications.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 the united states on (b)(6) 2021, it was reported that the patient's infusion set's tubing had disconnected at the site while inserting the set.The site location was her abdomen, and the pump was not used yet.The infusion sets were stored in a closet.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, her blood glucose level was 134 mg/dl.No further information available.

• Brand Name: MIO®
• Common Device Name: UNO INSET II 80/6 PCC GREY MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12364200
• Report Number: 3003442380-2021-00404
• Device Sequence Number: 14536267
• Product Code: FPA
• UDI-Device Identifier: 05705244007796
• UDI-Public: 05705244007796
• 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): 03/10/2022

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: 06/01/2022
• Device Model Number: MMT-965
• Device Lot Number: 5287817
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown