MAUDE Adverse Event Report: MIO¿ ADVANCE; UNO MIO ADV. GREY 60/6 SC1 10-PK INT

Lot Number 6001364

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in france.On (b)(6) 2024, the patient's parents reported that their child experienced hyperglycemia (400 mg/dl) for past one week.The parents stated that they received an alarm in the morning for resumption of basal around 09:00 am and blocked flow alarm at 09:13 am and on removal of catheter they noticed a bent cannula.Currently, the blood glucose level is 129 mg/dl.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.

• Brand Name: MIO¿ ADVANCE
• Type of Device: UNO MIO ADV. GREY 60/6 SC1 10-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18872796
• MDR Text Key: 337292020
• Report Number: 8021545-2024-00125
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018877
• UDI-Public: 05705244018877
• Combination Product (y/n): N
• PMA/PMN Number: K173879
• 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: 03/11/2024

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 Lot Number: 6001364
• Initial Date Manufacturer Received: 02/27/2024
• Initial Date FDA Received: 03/11/2024
• Patient Sequence Number: 1