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 a (b)(6) year-old female child patient faced a kinked cannula due to which she experienced high blood glucose level.Therefore, she tried to treat it with multiple daily injections, but on (b)(6) 2021, she went to the emergency room due to high blood glucose level.Her highest blood glucose level was over 500 mg/dl and she had traces of ketone level which the health care professional assessed it not to be dangerous/life threatening.Reportedly, the infusion had been used for less than a day.While in the emergency room, she received fluids of saline, insulin and unspecified medication intravenously as corrective treatment which resolved the issue.After staying for 12 hours in the emergency room, she was released on the same day with no permanent damage.Moreover, the patient again faced bent cannula issue on (b)(6) 2021 and (b)(6) 2021, respectively.The patient's blood glucose level was between 54-500 mg/dl at the time of the event.Further, they replaced the infusion set and insulin was resumed successfully.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
• MDR Report Key: 12360247
• MDR Text Key: 267889734
• Report Number: 3003442380-2021-00383
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1001680
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/10/2021
• Type of Device Usage: N
• Patient Sequence Number: 1