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

Model Number	1000275
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 experienced a kinked cannula issue.The patient's blood glucose level at the time of the incident was above 500 mg/dl which she tried to treat with a correction injection via multiple daily injection.The infusion set was used for less than a day and there was no damage when the package was first opened.Further, she generally inserted her sets on her abdomen.Subsequently, on (b)(6) 2020, the patient was admitted to the hospital as she unresponsive after going into diabetic ketoacidosis due to a kinked cannula issue (which was found at the hospital).Her highest blood glucose level was 775mg/dl.During hospitalization she was placed on a ventilator, given medication intravenously (drug name unknown), fluids, insulin, magnesium, potassium, etc.Which resolved the issue.On (b)(6) 2020, she was released from the hospital and she reported that her memory is off and is not the same.Moreover, it was mentioned that the patient replaced the infusion set and resumed insulin successfully.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: 10406414
• Report Number: 3003442380-2020-00357
• Device Sequence Number: 3085526
• 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 Expiration Date: 11/01/2022
• Device Model Number: 1000275
• Device Lot Number: 5299663
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1