MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/6 PCC

Lot Number	5166001
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
(b)(4).Event occurred in (b)(6).The patient reported that her infusion set's tubing broke off at the quick release in the night.She had issues with two quick sets from the same box.Reportedly, her blood glucose level went above 30 mmol/l and she corrected it with her pump.She did not know if pump was dropped or bumped.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 60/6 PCC
• MDR Report Key: 8447161
• Report Number: 3003442380-2019-00670
• Device Sequence Number: 10851372
• Product Code: FPA
• UDI-Device Identifier: 05705244006317
• UDI-Public: 05705244006317
• 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: 09/01/2019
• Device Lot Number: 5166001
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 03/25/2019
• Patient Sequence Number: 1