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) male child patient experienced high blood glucose level due to a bent cannula.Therefore, he tried to treat it was a bolus via pump, but subsequently, on (b)(6) 2021, the patient went to the emergency room due to high blood glucose level.His highest blood glucose level was above 700 mg/dl and had moderate ketone levels which the health care professional assessed not to be dangerous/life threatening.Moreover, the infusion set had been used for less than one day.While in the emergency room, he received fluids of saline, insulin, and unspecified intravenous medication (drug name unknown) as corrective treatment which resolved the issue.After staying for four hours in the emergency room, on the same day ((b)(6) 2021), the patient was released with no permanent damage.Moreover, it was also reported that patient's site ripped out while playing, one set had a bent cannula, insertion site was hard where needle was inserted and had a pus build up due to which he experienced high blood glucose level.Further, they removed the set and treated it with a correction bolus via pump.His highest blood glucose level was below 500 mg/dl and had moderate ketone level which the healthcare professional assessed not to be dangerous/life threatening.The patient did not notice any damage to the infusion sets when the package was first opened.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.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: 12082474
• MDR Text Key: 258880585
• Report Number: 3003442380-2021-00303
• 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: 06/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 12/01/2023
• Device Model Number: 1001680
• Device Lot Number: 5338607
• Date Manufacturer Received: 06/22/2021
• Type of Device Usage: N
• Patient Sequence Number: 1