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

Model Number MMT-943A600

Device Problem Material Integrity Problem (2978)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2022, the patient's mother reported that her daughter faced an insulin flow block which started last night.At the time of the event, her blood glucose level was 25 mmol/l, and she changed her site three times.The patient stated that the insulin exited from her infusion set tubing, but the tubing was bent.She pulled the tubing and then the insulin came out.Further, the patient changed full infusion and did not experienced issues with filling tubing.No further information available.

• Brand Name: MIO
• Type of Device: UNO INSET II 60/6 SC1 BLUE MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15705835
• MDR Text Key: 307264220
• Report Number: 3003442380-2022-01092
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244020337
• UDI-Public: 05705244020337
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MMT-943A600
• Device Lot Number: 5368853
• Date Manufacturer Received: 10/14/2022
• Patient Sequence Number: 1