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

Model Number MMT-923

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 while unwinding the infusion set's tubing before insertion, it accidently pulled out the set at the tubing connector and this issue occurred a couple of weeks ago.Currently, patient's blood glucose level was 152 mg/dl.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

Event Description

On 12-may-2021: follow up information was submitted to update the lot number, expiry date and awareness date.Moreover, the result of complaint investigation of the returned used device (2 sets) 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 while unwinding the infusion set's tubing before insertion, it accidently pulled out the set at the tubing connector and this issue occurred a couple of weeks ago.Currently, patient's blood glucose level was 152 mg/dl.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO
• Type of Device: UNO INSET II 60/6 PCC PINK MIMX
• MDR Report Key: 11647334
• MDR Text Key: 244890986
• Report Number: 3003442380-2021-00207
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/01/2023
• Device Model Number: MMT-923
• Device Lot Number: 5323777
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/12/2021
• Supplement Dates Manufacturer Received: 05/05/2021
• Supplement Dates FDA Received: 05/12/2021
• Patient Sequence Number: 1