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 approximately, the patient experienced a bent cannula symptoms/ issue which were noticed after three hours of insertion.Further, it was stated that the cannula was bent at ninety-degree angle and the infusion set had been used for one day.At the time of the event, his blood glucose level was 840 mg/dl which they tried to treat with a correction bolus via the pump.Consequently, he first went to the emergency room, where he stayed for three hours and was then hospitalized, as he experienced diabetic ketoacidosis.Reportedly, he was admitted in the step-down intensive care unit.During hospitalization, he received fluids of saline, insulin, and some unspecified medication intravenously (drug name unknown) as corrective treatment which resolved the issue.Moreover, he stayed in hospital for three days and two nights and was released on approximately (b)(6) 2021 (based on arrival information provided), 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: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13070746
• MDR Text Key: 282718292
• Report Number: 3003442380-2021-00842
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002817
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/14/2021
• Patient Sequence Number: 1