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

Model Number 1002823

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 experienced high blood glucose level due to a kinked cannula.Therefore, they tried to treat it with multiple daily injections, but on (b)(6) 2022, the patient went to the emergency room due to high blood glucose level.His highest blood glucose level was between 600-700 mg/dl, and he had high ketone levels which his healthcare professional assessed as dangerous/life threatening.Moreover, the infusion set had been used for 3 days.After spending four hours in the emergency room, the patient was transferred to the intensive care unit.During hospitalization, he received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2022, the patient was released from the hospital with no permanent damage.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 BLUE TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14390040
• MDR Text Key: 291600797
• Report Number: 3003442380-2022-00657
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018303
• UDI-Public: 05705244018303
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002823
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/03/2022
• Patient Sequence Number: 1