MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/9 PCC

Lot Number	5211906
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 while sleeping the infusion set's tubing came apart from the connector.The site was at the left side of stomach and the pump was in the pocket, clipped to the shirt.The infusions had been in use for 12 hours.The infusions were stored in a dry closet.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 60/9 PCC
• MDR Report Key: 8447142
• Report Number: 3003442380-2019-00624
• Device Sequence Number: 18918496
• Product Code: FPA
• UDI-Device Identifier: 05705244006393
• UDI-Public: 05705244006393
• 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: 11/01/2020
• Device Lot Number: 5211906
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 03/25/2019
• Patient Sequence Number: 1