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 an (b)(6) female child patient experienced high blood glucose level due to a viral infection and a bent cannula which was identified when the site was removed.Therefore, they tried to treat it with multiple daily injection, but on (b)(6) 2021, the patient went to the emergency room due to high blood glucose level.She had high ketone levels which her healthcare professional assessed not to be dangerous level/life threatening.Her highest blood glucose level was 440 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) as corrective treatment which resolved the issue.After staying for five and a half 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 her.Since the beginning of (b)(6)2021, the patient faced kinked cannula symptoms/issue noticed within 3 hours of insertion, approximately five events have occurred, and first event occurred (b)(6) 2021 (approximately).Her blood glucose level was approximately around 300 mg/dl for all the events.Moreover, 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: 12709801
• MDR Text Key: 278768468
• Report Number: 3003442380-2021-00624
• 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 Model Number: 1002817
• Device Lot Number: 5349733
• Date Manufacturer Received: 10/23/2021
• Type of Device Usage: N
• Patient Sequence Number: 1