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

Model Number MMT-923A600

Device Problem Infusion or Flow Problem (2964)

Patient Problem Hypoglycemia (1912)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, the patient's mother reported that the patient received insulin flow block.The blood glucose level was reported as 7.4 mmol/l and the infusion set had been used for few hours.Reportedly, the site of insertion was the patient's arm.No further information available.

• Brand Name: MIO
• Type of Device: UNO INSET II 60/6 SC1 PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12679515
• MDR Text Key: 277839915
• Report Number: 3003442380-2021-00622
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244020245
• UDI-Public: 05705244020245
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/01/2024
• Device Model Number: MMT-923A600
• Device Lot Number: 5350758
• Initial Date Manufacturer Received: 10/14/2021
• Initial Date FDA Received: 10/22/2021
• Type of Device Usage: N
• Patient Sequence Number: 1