MAUDE Adverse Event Report: MIO®; UNO INSET II 60/6 SC1 PINK MCAN

Model Number	MMT-923A600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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).On (b)(6) 2021, the patient report that two of her infusion set's tubing detached where it connects while sleeping.The site location was her abdomen, and the pump was located on her belt while sleeping.Moreover, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.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 the (complaint investigation) of returned used devices (2 tubing's), showed that the tubing was detached from the tubing connector (both samples).Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number 1474315 event occurred in canada on (b)(6)2021, the patient report that two of her infusion set's tubing detached where it connects while sleeping.The site location was her abdomen, and the pump was located on her belt while sleeping.Moreover, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: MIO®
• Common Device Name: UNO INSET II 60/6 SC1 PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12286416
• Report Number: 3003442380-2021-00352
• Device Sequence Number: 14620656
• Product Code: FPA
• UDI-Device Identifier: 05705244020245
• UDI-Public: 05705244020245
• 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): 03/04/2022

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: 01/01/2023
• Device Model Number: MMT-923A600
• Device Lot Number: 5309815
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 02/28/2022
• Initial Report FDA Received Date: 08/06/2021
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown