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

Lot Number	5256218
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 bent cannula issue due to which he experienced high blood glucose level reported to be 540 mg/dl.It was treated with a bolus and when that did not work, he was given an injection on the way to the emergency room.The patient's blood glucose level was at 350 mg/dl when he arrived at the emergency room.He also had a high level of ketones, which was identified as dangerous by a healthcare professional.At the emergency room, his blood work was taken, insulin was given, and an unknown medication was administered through intravenous route.The patient spent 4-5 hours in the emergency room and was subsequently admitted to the hospital.At the hospital, blood work was performed, and unspecified medication was administered through intravenous route, which resolved the issue.There was no permanent damage to the patient.The patient spent at least three days in the hospital.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: 8721254
• Report Number: 3003442380-2019-01556
• Device Sequence Number: 1685644
• 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: 09/01/2021
• Device Lot Number: 5256218
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 06/21/2019
• Patient Sequence Number: 1