MAUDE Adverse Event Report: AUTOSOFT 90¿; INSET II 60/6 GREY

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 experienced high blood glucose level, which she tried to self-treat with a correction bolus and by replacing her infusion set supplies.Thereafter, the patient had to go to the emergency room due to elevated blood glucose level caused by three kinked infusion set sites in the past 24 hours leading to the emergency room visit.The patient's blood glucose level was in 700s mg/dl at the time of arrival and the patient's level of ketones was assessed to be dangerous/life threatening by a healthcare professional.The patient received insulin drip and fluids in the emergency room.She stayed there for four hours and was subsequently hospitalized with blood glucose level in 500s mg/dl.The staff at the hospital was under the impression that she might have had a heart attack.In the hospital, she received insulin and blood thinners as corrective treatment, which resolved the issue.There was no permanent damage to the patient.The infusion set had been in use for less than one day.She stayed in the hospital for four 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: AUTOSOFT 90¿
• Common Device Name: INSET II 60/6 GREY
• MDR Report Key: 8721249
• Report Number: 3003442380-2019-01555
• Device Sequence Number: 2115025
• Product Code: FPA
• UDI-Device Identifier: 05705244014992
• UDI-Public: 05705244014992
• 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: 06/04/2019
• Initial Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1