MAUDE Adverse Event Report: INSET¿; INSET I 60/6 GREY

Lot Number	5136243
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 issued with the infusion set in the form of bent cannula, which was noticed at the hospital.Reportedly, the blood glucose was 1100 mg/dl and he experienced diabetic ketoacidosis, upon arrival in the emergency room.Prior to hospitalization, he self-treated with a bolus from the pump and confirmed that he successfully delivered all boluses.In the emergency room, the patient stayed for a few hours and was put under warm blankets and received intravenous insulin drip and fluids.The patient felt a bit better and had a less urge to vomit, when left the emergency room.Subsequently he was hospitalized, where he received electrolytes, intravenous insulin drip, and resumed insulin from the pump which resolved the issue.The blood glucose was 395 mg/dl the night before this report and 267 mg/dl at the time of this report.The infusion set was used for one and a half day.He was admitted for three days.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: INSET¿
• Common Device Name: INSET I 60/6 GREY
• MDR Report Key: 8517416
• Report Number: 3003442380-2019-01244
• Device Sequence Number: 19200923
• Product Code: FPA
• UDI-Device Identifier: 05705244006874
• UDI-Public: 05705244006874
• 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: 5136243
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2017
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1