MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; UNO QUICK-SET 110/9 SC1 MECA

Model Number MMT-396A

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

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 she had two sets that failed, as it was hot and humid and was working outside, so the glue was not sticking, and she did not get insulin.Reportedly, she was just sitting on the couch.Further, she changed her set because she caught it right away and put the new set on it later.However, her blood glucose level was fine but the infusion set's tubing broke (infusion set tubing came apart) four inches away from where it connects to the body and she did not know what happened.The site location was left side of her body and the pump was also on the left side.The infusion had been used for six hours.The infusion sets were stored or used in a place where they might have been exposed to extreme temperatures and humidity (i.E.Sauna, inside car, unconditioned garages, etc) because it was humidity outside while wearing it and temperature was in the 80s.There was no stress or pull on the tubing and the pump was not dropped with the set connected to her body.Currently, her blood glucose level was 88 mg/dl.No further information available.

Event Description

On (b)(6) 2021: follow up information was submitted to update awareness date and the result of complaint investigation of the returned used device (1 set) showed that tubing was damaged (was found cut).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 she had two sets that failed, as it was hot and humid and was working outside, so the glue was not sticking, and she did not get insulin.Reportedly, she was just sitting on the couch.Further, she changed her set because she caught it right away and put the new set on it later.However, her blood glucose level was fine but the infusion set's tubing broke (infusion set tubing came apart) four inches away from where it connects to the body and she did not know what happened.The site location was left side of her body and the pump was also on the left side.The infusion had been used for six hours.The infusion sets were stored or used in a place where they might have been exposed to extreme temperatures and humidity (i.E.Sauna, inside car, unconditioned garages, etc) because it was humidity outside while wearing it and temperature was in the 80s.There was no stress or pull on the tubing and the pump was not dropped with the set connected to her body.Currently, her blood glucose level was 88 mg/dl.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: UNO QUICK-SET 110/9 SC1 MECA
• MDR Report Key: 12073749
• MDR Text Key: 258659773
• Report Number: 3003442380-2021-00296
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018051
• UDI-Public: 05705244018051
• 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: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2024
• Device Model Number: MMT-396A
• Device Lot Number: 5342455
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1