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

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.It was reported that the patient had faced bent cannula issue and had high blood glucose levels, which she self-treated with correction boluses.Reportedly, on arrival in the emergency room, the blood glucose level was 500 mg/dl and the health care professional assessed it as dangerous/ life threatening.The patient was in the emergency room for four hours and was given intravenous insulin.The patient still experienced high blood glucose and diabetic ketoacidosis.Subsequently she was admitted to the hospital.During hospitalization, she received intravenous insulin as corrective treatment which resolved the issue.She was admitted for one and a half week and there was no permanent damage to the patient.The infusion set was used for two days.Currently, she was on multiple daily injections.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.This case has a sister complaint pr id: (b)(4), which was also reported.No further information available.

• Brand Name: AUTOSOFT 90
• Common Device Name: INSET II 60/6 GREY TCAP
• MDR Report Key: 8563407
• Report Number: 3003442380-2019-01124
• Device Sequence Number: 11342736
• Product Code: FPA
• UDI-Device Identifier: 05705244014305
• UDI-Public: 05705244014305
• 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: 07/25/2018
• Initial Report FDA Received Date: 04/30/2019
• Patient Sequence Number: 1