MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 110/6 GREY TCAP 10PK INT

Model Number 1001728

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 on (b)(6) 2022, the patient faced an alarm because of a kinked cannula at night due to which she experienced high blood glucose level (over 700 mg/dl).Therefore, they tried to treat it with correction injection via multiple daily injections, but the next day (b)(6) 2022), the patient's mother took her to the emergency room, and she was subsequently hospitalized due to her high blood glucose level, after spending 6-7 hours in the emergency room.She had high/large ketone level which was assessed as dangerous/life threatening by her healthcare professional.Moreover, the infusion set had been used for 12 hours and the expiration date of the infusion set is (b)(6) 2024.Further, the patient was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin and potassium which resolved the issue.On the (b)(6) 2022, the patient was released from the hospital with no permanent damage.Further, on (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022 and (b)(6) 2022, the patient again faced kinked cannulas, for two events within 3 hours of insertion and for other three events, for 3 or more hours after insertion.For all the events, the site location was patient's abdomen and the blood glucose level for was ranging between 300-350 mg/dl at the time of the event.Also, the patient had moderate ketone level which her healthcare professional did not assessed as dangerous/life threatening.For all the events, they tried to treat the high blood glucose level with correction bolus via pump after changing the infusion set.Furthermore, 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 110/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15333335
• MDR Text Key: 299042467
• Report Number: 3003442380-2022-00992
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016927
• UDI-Public: 05705244016927
• 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: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001728
• Device Lot Number: 5359514
• Date Manufacturer Received: 08/23/2022
• Patient Sequence Number: 1