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

Lot Number	5208243
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).The patient's husband reported that for the last four days prior to this report, the patient had high blood glucose level and self-treated it with multiple daily injection.The patient went to the hospital with diabetes ketoacidosis overnight.The patient stated that set was leaking at the quick release as it was not tightly connected, and this issue occurred with three sets.They noticed a crack in the quick release.Reportedly, the pump was not dropped with set in place.The patient was hospitalized for more than 3 days.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 60/6 PCC
• MDR Report Key: 8384852
• Report Number: 3003442380-2019-00596
• Device Sequence Number: 11288955
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 12/01/2020
• Device Lot Number: 5208243
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 03/03/2019
• Patient Sequence Number: 1