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

Lot Number	UNKNOWN
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in canada.On 18/mar/2024 and 09/apr/2024, it was reported that the patient encountered insulin flow blocked after 5-10 seconds which led to high blood glucose level of 18.5 mmol/l.The patient's current blood glucose value (at time of call) was 18.5 mmol/l.The patient received bolus as corrective treatment.The infusion set last changed 2 days ago prior to the event.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: 19294855
• Report Number: 3003442380-2024-00976
• Device Sequence Number: 15244395
• Product Code: FPA
• UDI-Device Identifier: 05705244020245
• UDI-Public: 05705244020245
• 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): 05/11/2024

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: 04/12/2024
• Initial Report FDA Received Date: 05/11/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown