MAUDE Adverse Event Report: AUTOSOFT¿ XC; UNO INSET I 60/6 GREY TCAP 10PK INT

Model Number 1001680

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient experienced high blood glucose level due to a kinked cannula as the insulin appeared to be retained where the tubing connects to the site and the cannula appeared to be kinked.Therefore, they tried to treat it with bolus via pump, but on (b)(6) 2021, the patient first went to the emergency room and after spending four hours, subsequently, she was hospitalized and transferred to the intensive care unit due to high blood glucose level.Her highest blood glucose was 900 mg/dl, and her ketone levels were assessed as dangerous/ life threatening by her heath care professional.The infusion had been used for 24 hours.While in the hospital, she received fluids of saline, insulin, and unspecified intravenous medication (drug name unknown) for one and a half days, multiple daily injection of lantis and humalog for one day as corrective treatment which resolved the issue.On (b)(6) 2021, she was released from the hospital with no permanent damage.On the next day ( (b)(6) 2021), she switched to pump therapy.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¿ XC
• Type of Device: UNO INSET I 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12768806
• MDR Text Key: 280445666
• Report Number: 3003442380-2021-00653
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001680
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 10/28/2021
• Patient Sequence Number: 1