MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 110/6 PCC

Lot Number	5198456
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient reported that her infusion set detached from the site at the quick release when she was in the house.She was unable to get the set to lock back successfully with her site.Subsequently, she experienced high blood glucose level, which was treated with a manual injection and she also changed her set.The site location was above belly button and the pump was on the same side as the site.The infusion had been in use for less than 24 hours and 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 the patient's body.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 110/6 PCC
• MDR Report Key: 8512006
• Report Number: 3003442380-2019-01119
• Device Sequence Number: 1921375
• Product Code: FPA
• UDI-Device Identifier: 05705244006676
• UDI-Public: 05705244006676
• 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: 08/25/2017
• Device Lot Number: 5198456
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2018
• Initial Report FDA Received Date: 04/13/2019
• Patient Sequence Number: 1