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

Lot Number	UNKNOWN
Medical Device Problem Code	Loss of or Failure to Bond (1068)
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 france.On (b)(6) 2024, it was reported that patient faced an issue with infusion set tape was not sticking.Patient had reported that product not adhering enough long.Patient had to change infusion set earlier than the seven days expected no further information available.
Additional Manufacturer Narrative
Mdr 3003442380-2024-02078 - device 1 of 9.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19354245
• Report Number: 3003442380-2024-02562
• Device Sequence Number: 7466608
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• Combination Product (Y/N): N
• 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): 05/20/2024

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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2024
• Initial Report FDA Received Date: 05/20/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown