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

Lot Number	5170706
Medical Device Problem Code	Material Twisted/Bent (2981)
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 by the patient's wife, that four weeks ago, her husband had experienced an issue with the infusion set in the form of bent cannula.The patient was sick and thought that he had flu.Moreover, his heart was in distress, his hands were shaking and had vomiting and nausea.Reportedly the patient had high blood glucose levels which was treated with 30 units of insulin, manual injection by his wife.Another 15 units were given later.The patient went to the bathroom and fell on the ground, so emergency medical services were called, and he was taken to the emergency room.The patient's blood glucose went up to 740 mg/dl and he experienced diabetic ketoacidosis.During hospitalization, they took the cannula off and noticed that it was crimped.They had to do a heart catheterization on him because troponin (heart enzymes) was very high.The patient was in the intensive care unit for three days.He was hospitalized for four days and was treated with some unspecified drugs via the intravenous route, heart catheterization and electrolytes.She also reported that her husband changed the set twice a week.The patient's current blood glucose was 300 mg/dl.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 46/6 PCC
• MDR Report Key: 8517248
• Report Number: 3003442380-2019-01240
• Device Sequence Number: 16605937
• 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: 5170706
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2017
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1