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

Lot Number UNKNOWN

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, the patient reported that the infusion set's tubing came apart near the tubing connector.The site location was patient's left abdomen and the pump was in her bra.Moreover, the infusion had been used for one day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, her blood glucose level was 69 mg/dl.No further information available.

Event Description

On 26-apr-2021: follow up information was submitted to update the awareness date.Moreover, the result of the (complaint investigations) visual inspection and tests for static pull of tubing-tubing/pcap connector tests were performed on the returned used device (one tubing) which showed that all test results were within specifications.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, the patient reported that the infusion set's tubing came apart near the tubing connector.The site location was patient's left abdomen and the pump was in her bra.Moreover, the infusion had been used for one day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, her blood glucose level was 69 mg/dl.No further information available.

• Brand Name: MIO
• Type of Device: UNO INSET II 60/6 SC1 BLUE MIMX
• MDR Report Key: 11336330
• MDR Text Key: 233575834
• Report Number: 3003442380-2021-00149
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/09/2021
• Patient Sequence Number: 1