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

Lot Number 5409896

Device Problem Detachment of Device or Device Component (2907)

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) 2024, it was reported that patient's infusion set's tubing became loose from the tubing connector while waking up and experienced high blood glucose level.The site location was patient's abdomen under the naval, with the pump in the left side pocket.Moreover, the infusion had been used for one day.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 dropped with the set connected to patient's body.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: 19001536
• MDR Text Key: 339007575
• Report Number: 3003442380-2024-00205
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017573
• UDI-Public: 05705244017573
• Combination Product (y/n): N
• 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
• Report Date: 03/29/2024

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 Lot Number: 5409896
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/28/2024
• Patient Sequence Number: 1