MAUDE Adverse Event Report: MIO; UNO INSET II 80/9 PCC GREY MIMX

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 the united states on (b)(6) 2024, it was reported that the patient received insulin flow blocked alarm and the blood glucose level went over 300 mg/dl, which they tried to treat with an injection.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 PCC GREY MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19198786
• Report Number: 3003442380-2024-00238
• Device Sequence Number: 7658624
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• 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): 04/26/2024

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: 04/10/2024
• Initial Report FDA Received Date: 04/27/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown