MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 PCC BLUE MIMX

Lot Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event 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
• Type of Device: UNO INSET II 60/6 PCC BLUE MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18989945
• MDR Text Key: 338746566
• Report Number: 3003442380-2024-00203
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: 03/23/2024
• Initial Date FDA Received: 03/27/2024
• Patient Sequence Number: 1