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

Lot Number	5221995
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 reported that her three infusion sets broke at the quick release, 3 times in 3 consecutive dates while she was sleeping.Further, leakage was observed because of the breakage.All the infusion sets were from the same box.On (b)(6) 2019, she had high blood glucose level of 27.9 mmol/l (at the time of the incident).Subsequently, on the same day at 6 am, she was taken to emergency room as she was not feeling well at all, was dizzy and disoriented, had nausea and vomiting, thus was hospitalized for one day.During hospitalization, she received manual injections.Currently, her blood glucose level was 7.1 mmol/l and she was using a different infusion set from a different box.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 60/9 PCC
• MDR Report Key: 9537484
• Report Number: 3003442380-2020-00100
• Device Sequence Number: 16715212
• 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: 01/01/2022
• Device Lot Number: 5221995
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 01/02/2020
• Patient Sequence Number: 1