MAUDE Adverse Event Report: T:90¿ INFUSION SET; INSET II 60/6 GREY

Lot Number	5114100
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.The patient experienced symptoms of diabetic ketoacidosis and high blood glucose level, which he attempted to treat with a correction bolus.He took a dinner bolus as well prior to experiencing diabetic ketoacidosis.Subsequently, he went to the emergency room with blood glucose level at 808 mg/dl, which was treated with insulin through intravenous route.When he left the emergency room after six hours, his blood glucose level was at 600 mg/dl and his condition was stable.However, he was transferred to the intensive care unit for further treatment.In the hospital, the healthcare professionals saw that he had a bent cannula.He received insulin via intravenous route and magnesium as corrective treatment in the hospital, which resolved the issue.The infusion set had been in use for two days and the patient stayed in the hospital for four days.There was no permanent damage to the patient.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: T:90¿ INFUSION SET
• Common Device Name: INSET II 60/6 GREY
• MDR Report Key: 8543316
• Report Number: 3003442380-2019-01412
• Device Sequence Number: 10840855
• Product Code: FPA
• UDI-Device Identifier: 05705244004412
• UDI-Public: 05705244004412
• Combination Product (Y/N): N
• PMA/510(K) Number: K032854
• 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: 5114100
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2017
• Initial Report FDA Received Date: 04/24/2019
• Patient Sequence Number: 1