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
(b)(4).Event occurred in the united states.The patient reported bent cannula issues twice due to which the patient experienced high blood glucose level, which was self-treated with correction boluses and by changing sites.Since the correction boluses did not bring the blood sugar level down, the patient went to the emergency room with high blood glucose level between 500 mg/dl and 600 mg/dl.Furthermore, the patient had large ketones with its level identified as dangerous/life threatening by a healthcare professional.Highest blood glucose level reported was in 600s mg/dl.The patient was given insulin via intravenous route and glucose.The patient stayed there for a few hours and was stable when the patient left the emergency room.Subsequently, the patient was hospitalized where the patient received insulin via intravenous route and glucose, which resolved the issue.The infusion set had been in use for 48 hours.There was no permanent damage to the patient.The patient was released from the hospital after 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: 8539119
• Report Number: 3003442380-2019-01359
• Device Sequence Number: 2431778
• 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: 12/21/2016
• Initial Report FDA Received Date: 04/23/2019
• Patient Sequence Number: 1