MAUDE Adverse Event Report: MIO ADVANCE; UNO MIO ADV. GREY 110/9 SC1 10-PK INT

Lot Number 5339016

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that a couple of weeks ago, the tubing clip disconnected from the site, underneath a car as he rolled over and heard it disconnect and it seemed like by just squeezing one side of the lock, while doing mechanic work.The site location was on his left side of his abdomen and the pump was located on the right hip.The infusion had been used since (b)(6) 2021 (09:30 pm).Reportedly, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, his blood glucose level was 95 mg/dl.No further information available.

Event Description

On 24-may-2021: follow up information was submitted to update the brand name, common device name, unique identifier (udi) number, pma/510(k) number and the result of complaint investigation of the returned used device (1 set inserted) showed that all the test results were within specification.Based on the result: medical device problem code, component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that a couple of weeks ago, the tubing clip disconnected from the site, underneath a car as he rolled over and heard it disconnect and it seemed like by just squeezing one side of the lock, while doing mechanic work.The site location was on his left side of his abdomen and the pump was located on the right hip.The infusion had been used since (b)(6) 2021 (09:30 pm).Reportedly, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, his blood glucose level was 95 mg/dl.No further information available.

• Brand Name: MIO ADVANCE
• Type of Device: UNO MIO ADV. GREY 110/9 SC1 10-PK INT
• MDR Report Key: 11647326
• MDR Text Key: 250000423
• Report Number: 3003442380-2021-00204
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K173879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/01/2023
• Device Lot Number: 5339016
• Date Manufacturer Received: 05/13/2021
• Patient Sequence Number: 1