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

Lot Number	5150088
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.It was reported that the patient had experienced an issue with the infusion set in the form of bent cannula which led to elevated blood glucose levels.He self-treated it with bolus and manual injections.Reportedly, the patient was taken to the emergency room as his blood glucose was over 500 mg/dl and had ketones.The health care professional assessed the ketone level as dangerous/life threatening.In the emergency room, he stayed for a couple of hours and he received intravenous fluids and insulin.His blood glucose remained high and he was still had diabetic ketoacidosis, thus he was admitted to the hospital later in the day.During hospitalization he received, intravenous fluids and insulin which resolved the issue and there was no permanent damage to the patient.The infusion set was used for about 48 hours at the time of the hospitalization.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 60/9 GREY
• MDR Report Key: 8517506
• Report Number: 3003442380-2019-01250
• Device Sequence Number: 13933288
• 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?: No
• Operator of Device: No Information
• Device Lot Number: 5150088
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2017
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1