MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 2-PACK 60/6 GREY TCAP

Model Number 1000281

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 male child patient faced a kinked cannula after more than three hours of insertion, due to which he experienced high blood glucose levels.To treat the issue, correction injection via multiple daily injection was administered.This issue occurred with five infusion sets between 01-aug-2021 and 31-aug-2021.Reportedly, for the first four events, his blood glucose level was in the range of 54-500 mg/dl (3.0-27.7 mmol/l).However, on (b)(6) 2021, his blood glucose level was over 500 mg/dl and the infusion set was used for three days.Moreover, he had high ketones, which were not dangerous/life threatening, as assessed by his health care professional.However, the patient was taken to the emergency room, where he received fluids of saline and insulin as corrective treatment which resolved the issue.He stayed in the emergency room for 4 to 5 hours.On the same day ((b)(6) 2021, he was released from the hospital with no permanent damage.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 90
• Type of Device: INSET II 2-PACK 60/6 GREY TCAP
• MDR Report Key: 12518272
• MDR Text Key: 272867258
• Report Number: 3003442380-2021-00499
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014541
• UDI-Public: 05705244014541
• 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
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1000281
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/14/2021
• Type of Device Usage: N
• Patient Sequence Number: 1