MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 46/6 PCC

Lot Number	5233496
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported having issues with the reservoir and quick set.While changing the infusion set, she noticed that the tubing was bent at the end and when she inserted, it hurt.She experienced high blood glucose level, which she was able to treat.Prior to the event, she was simply walking around the house.The site location was her leg and the pump was worn on her waist.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 her body.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 46/6 PCC
• MDR Report Key: 8338280
• Report Number: 3003442380-2019-00570
• Device Sequence Number: 1717709
• Product Code: FPA
• UDI-Device Identifier: 05705244006232
• UDI-Public: 05705244006232
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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
• Operator of Device: No Information
• Device Expiration Date: 08/01/2021
• Device Lot Number: 5233496
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/14/2019
• Patient Sequence Number: 1