MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 PCC BLUE 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 10-years-old female child patient had insulin flow block around 2:00 am resulting in no insulin for three hours.Her blood glucose level at the time of incident was 370 mg/dl and ketones were 1.8 mmol/l which resolved to 0.1 mmol/l in 1.5 hours after changing infusion set.No further information was available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 PCC BLUE MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18989945
• Report Number: 3003442380-2024-00203
• Device Sequence Number: 19547654
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• 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): 03/28/2024

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: 03/23/2024
• Initial Report FDA Received Date: 03/27/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown