MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 46/6 PCC

Lot Number	UNKNOWN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient had leakage from the infusion set tubing and was admitted to the hospital.The patient had high blood glucose level of 500 mg/dl and experienced diabetic ketoacidosis.The patient was admitted in the intensive care unit and was downgraded from there to the medicine surgery floor, in a regular room.The patient noticed cracks or splits in the tubing along the reservoir.The patient was hospitalized for two days.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 46/6 PCC
• MDR Report Key: 8517523
• Report Number: 3003442380-2019-01166
• Device Sequence Number: 1919847
• Product Code: FPA
• UDI-Device Identifier: 05705244006232
• UDI-Public: 05705244006232
• 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?: No
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1