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

Lot Number	5174289
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
(b)(4).Event occurred in (b)(6).The patient reported that on the day of this report, the infusion set's tubing separated at the infusion set attachment.The issue occurred on the fourth day of use.It had happened around two weeks ago also.It came to notice after he woke up from sleep with high blood glucose level, which he treated right away.The site was upper buttocks and the pump was on the same side attached with the belt clips.The patient did not seem to have stressed or pulled the tubing and the pump was not dropped.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 60/9 PCC
• MDR Report Key: 8458887
• Report Number: 3003442380-2019-00775
• Device Sequence Number: 2793261
• 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 Lot Number: 5174289
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 03/28/2019
• Patient Sequence Number: 1