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

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's mother reported that the patient faced bent cannula issues with 6-8 infusion sets.This resulted in high blood glucose level reported to be between 200 mg/dl and 300 mg/dl, at the time of this event.It was self-treated with a bolus and manual corrections.The patient also changed the site.The patient also tested positive for large ketone and the level of ketones was identified to be dangerous/life threatening by a healthcare professional.Highest blood glucose level reported was 588 mg/dl.Subsequently, the patient was admitted to the hospital where the patient received insulin and saline via intravenous route, which resolved the issue.Infusion set had been in use for one and a half day.The patient did not notice any damage when the package was first opened.There was no permanent damage to the patient.The patient stayed in the hospital for two 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 PINK
• MDR Report Key: 8539224
• Report Number: 3003442380-2019-01367
• Device Sequence Number: 16755016
• Product Code: FPA
• UDI-Device Identifier: 05705244006935
• UDI-Public: 05705244006935
• 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: 01/11/2017
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1