MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/9 GREY TCAP

Lot Number	5191528
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 faced a kinked cannula issue.She had high blood glucose levels and experienced diabetic ketoacidosis which she self-treated with a correction bolus by the pump.Her blood glucose level was 575 mg/dl, when she arrived at the emergency room and she stayed there for few hours.When she left from the emergency room, she was exhausted, had bruised and bandages at her elbow and her blood glucose was 119 mg/dl.Subsequently, she was admitted to the intensive care unit and it was discovered after she was admitted to the hospital that her cannula was kinked.Her highest blood glucose reported was 578 mg/dl.The patient was treated with insulin drip and anti-nausea medication in the emergency room and during hospitalization which resolved the issue.She was hospitalized for four days and there was no permanent damage to the patient.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 60/9 GREY TCAP
• MDR Report Key: 8547999
• Report Number: 3003442380-2019-01302
• Device Sequence Number: 1743552
• Product Code: FPA
• UDI-Device Identifier: 05705244014367
• UDI-Public: 05705244014367
• 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: 5191528
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/25/2019
• Patient Sequence Number: 1