MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Model Number 1002817

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) 2021, a (b)(6) year-old male child patient experienced high blood glucose level due to a bent cannula.Therefore, they tried to treat it with some unspecified fluids intravenously, but subsequently, on the same day ((b)(6) 2021), the patient went to the emergency room due to diabetic ketoacidosis.He had high ketone levels which his healthcare professional assessed as dangerous levels.Her highest blood glucose level was over 400 mg/dl and the infusion had been used for two days.While in the emergency room, the patient received fluids, of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.After staying for six hours in the emergency room, on the same day ((b)(6) 2021), the patient was released from the emergency room with no permanent damage caused to him.Previously, on (b)(6) 2021 and (b)(6) 2021, the patient faced kinked cannula symptoms/issue noticed within 3 hours of insertion and his blood glucose level was in between 200-400 mg/dl.Moreover, this issue occurred with around ten infusion sets.Further, they replaced the infusion set, cartridge 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: UNO INSET II 60/6 GREY TCAP 10PK INT
• MDR Report Key: 12709156
• MDR Text Key: 278765769
• Report Number: 3003442380-2021-00623
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• 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: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/01/2024
• Device Model Number: 1002817
• Device Lot Number: 5349704
• Date Manufacturer Received: 10/23/2021
• Type of Device Usage: N
• Patient Sequence Number: 1