MAUDE Adverse Event Report: INSET¿; INSET I 60/9 GREY

Lot Number	UNKNOWN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that her infusion set's tubing broke off from the base of the connecter piece that was clipped into her site, which caused high blood glucose level, in the middle of the night.The patient went to the emergency room, as she experienced diabetes ketoacidosis symptoms along with high blood glucose level (900 mg/dl).She was treated with insulin drip and fluids few hours in emergency room, but she felt unstable and was subsequently admitted to the intensive care unit.The patient received insulin drip and intravenous fluids as corrective treatment which resolved the issue.The infusion set was in use for a day and a half.The patient was hospitalized for few days.No further information available.

• Brand Name: INSET¿
• Common Device Name: INSET I 60/9 GREY
• MDR Report Key: 8467995
• Report Number: 3003442380-2019-00858
• Device Sequence Number: 11242858
• Product Code: FPA
• UDI-Device Identifier: 05705244006881
• UDI-Public: 05705244006881
• 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?: Yes
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 03/31/2019
• Patient Sequence Number: 1