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

Lot Number 5338929

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that the patient experienced chest pain, increased thirst, and high blood glucose level due to a bent cannula.Therefore, on (b)(6) 2021, at 10:00 am, the patient was admitted to the hospital due to diabetic ketoacidosis and blood glucose level of 415 mg/dl.Moreover, the infusion had been used for one day.During hospitalization, the patient received intravenous insulin infusion as corrective treatment.The patient stayed in the hospital for two days.Currently, the patient's blood glucose level was 101 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 available.

• Brand Name: MIO¿
• Type of Device: UNO INSET II 60/6 SC1 PINK MIMX
• MDR Report Key: 12427047
• MDR Text Key: 270290597
• Report Number: 3003442380-2021-00434
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• 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

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: 10/01/2023
• Device Lot Number: 5338929
• Initial Date Manufacturer Received: 08/27/2021
• Initial Date FDA Received: 09/06/2021
• Type of Device Usage: N
• Patient Sequence Number: 1