MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; UNO QUICK-SET 60/9 SC1 MECA

Model Number MMT-397A

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 the infusion set's tubing was not staying inserted as the plastic show heat lines and glue was pulled out.It pulled off from the body at the site location while the patient was sleeping, and the patient experienced high blood glucose level which they tried to treat it with manual injection.The site location was patient's leg, and the pump was located at the side.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.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 121 mg/dl.No further information available.

Event Description

On 01-oct-2021: follow up information was submitted to update awareness date and the result of complaint investigation of the returned used device (two sets) 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, it was reported that the infusion set's tubing was not staying inserted as the plastic show heat lines and glue was pulled out.It pulled off from the body at the site location while the patient was sleeping, and the patient experienced high blood glucose level which they tried to treat it with manual injection.The site location was patient's leg, and the pump was located at the side.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.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 121 mg/dl.No further information available.

Event Description

On 30-mar-2022 iv: follow up information was submitted to update the unique identifier (udi) number and awareness date.On 01-oct-2021: follow up information was submitted to update awareness date and the result of complaint investigation of the returned used device (two sets) 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 29-jul-2021, it was reported that the infusion set's tubing was not staying inserted as the plastic show heat lines and glue was pulled out.It pulled off from the body at the site location while the patient was sleeping, and the patient experienced high blood glucose level which they tried to treat it with manual injection.The site location was patient's leg, and the pump was located at the side.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.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 121 mg/dl.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: UNO QUICK-SET 60/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12317418
• MDR Text Key: 266390775
• Report Number: 3003442380-2021-00371
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017559
• UDI-Public: 5705244017559
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/30/2022

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 Expiration Date: 12/01/2023
• Device Model Number: MMT-397A
• Device Lot Number: 5342467
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/13/2021
• Supplement Dates Manufacturer Received: 09/19/2021; 03/17/2022
• Supplement Dates FDA Received: 10/01/2021; 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Patient Sequence Number: 1