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

Lot Number	UNKNOWN
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 faced kinked cannula issues thrice that resulted in high blood glucose level each time.The first time, the patient also experienced diabetic ketoacidosis symptoms and self-treated it with a manual injection.The patient arrived at the emergency room with blood glucose level at 700 mg/dl.She received intravenous placement and stayed there for a few hours before getting transferred to the intensive care unit as her condition was unstable.Three weeks later, she again experienced diabetic ketoacidosis symptoms and took a correction bolus with the pump along with multiple daily injections.She went to the emergency room where she received intravenous placement and stayed there for a few hours before getting transferred to the intensive care unit as her condition was unstable.A month and a half before this report, the patient again experienced diabetic ketoacidosis symptoms and was taken to the emergency room.She was given intravenous placement and a shot for chest pain.She stayed in the emergency room for seven hours before getting transferred to the intensive care unit as her condition was unstable.All three times, the patient received insulin via intravenous drip, potassium, magnesium and manual injections in the hospital, which resolved the issue.The patient stayed in the hospital for two days the first two times, respectively, and last hospitalization duration was for seven days.There was no permanent damage to the patient all three times.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: 8538719
• Report Number: 3003442380-2019-01384
• Device Sequence Number: 1743971
• 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: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1