MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/6 PCC

Lot Number	5233450
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 that the infusion set's tubing had detached from her site at the quick release/ connector, which led to increased blood glucose levels, while she was in the class.The site location was left side of her abdomen and the pump was located on the same side.The infusion was being used for less than a day.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Upon investigation of returned used device (1 set), it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 80/6 PCC
• MDR Report Key: 9236692
• Report Number: 3003442380-2019-01875
• Device Sequence Number: 13491558
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• 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: 05/01/2021
• Device Lot Number: 5233450
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2018
• Initial Report FDA Received Date: 10/24/2019
• Patient Sequence Number: 1