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

Lot Number	5271734
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.On (b)(6) 2019, the patient had multiple bent cannula issue and experienced high blood glucose.Reportedly, infusion set was used for less than a day.She had vomiting and high blood glucose level (her continuous glucose monitoring indicated it as 400 mg/dl or above, but she did not confirm the value with her meter), which she tried to treat with the pump and by changing her supplies.On (b)(6) 2019, she was transported by the ambulance to the emergency room and upon arrival, her blood glucose level was 650 mg/dl and when she removed the infusion set there, she observed that the cannula was bent.Moreover, her ketone level was assessed dangerous/life threatening by health care professional.She stayed there for a few hours and received some unspecified fluids intravenously.She left the emergency room, with blood glucose level of 650 mg/dl and was subsequently admitted to the intensive care unit for diabetic ketoacidosis.She received some unspecified intravenous fluids, lantus and fast acting insulin for food boluses, as corrective treatment which resolved the issue.On (b)(6) 2019, she was discharged and had no permanent damage.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 TCAP
• MDR Report Key: 8958999
• Report Number: 3003442380-2019-01717
• Device Sequence Number: 19437334
• 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 Expiration Date: 02/01/2022
• Device Lot Number: 5271734
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/04/2019
• Patient Sequence Number: 1