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

Lot Number	5231111
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 issues with a bent cannula and was hospitalized due to diabetic ketoacidosis.He went to the emergency and stayed there for a couple of hours.Patient's blood glucose was over 700 mg/dl when arrived at the emergency room and received insulin through intravenous route as corrective treatment.He had large ketones and the health care professional assessed the ketone level as dangerous/life threatening.The patient was diagnosed with acute kidney failure, diabetic ketoacidosis, hyperglycemia, hyperkalemia and blood glucose level was 300 mg/dl when the patient left the emergency and was subsequently hospitalized.Reportedly, the patient noticed the cannula was bent when he pulled his site out while in the hospital.He was using the same infusion set for 5 days.The patient was treated with insulin drip, potassium and magnesium.He was hospitalized for more than 2 days and was still hospitalized at the time of the report.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: 8559712
• Report Number: 3003442380-2019-01401
• Device Sequence Number: 19216602
• 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: 03/01/2021
• Device Lot Number: 5231111
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 04/29/2019
• Patient Sequence Number: 1