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

Lot Number	5147674
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 had bent cannula and went to the emergency due to being unconscious from cardiac arrest and patient stated it was due to high blood glucose level.The patient stated that he received cardio-pulmonary resuscitation before being transported to the emergency.His blood glucose level was in 700s mg/dl when he arrived at the emergency room.The patient also had ketone levels.He self-treated himself with bolus via pump prior to being unconscious and being transported to the emergency.He was in the emergency room for less than a day and received fluids via intravenous route and was subsequently admitted to the intensive care unit.During hospitalization, when his cannula was removed it was bent.He was treated with intravenous fluids and insulin which resolved the issue.The infusion set had been in use for one day.Due to this event he had to have a cardiac defibrillator surgically implanted into his body.He was hospitalized for 10 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: 8548560
• Report Number: 3003442380-2019-01390
• Device Sequence Number: 2443415
• 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 Expiration Date: 06/01/2019
• Device Lot Number: 5147674
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2017
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1