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

Model Number 1001680

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 the patient experienced high blood glucose levels due to a bent cannula.Further, she had a stroke and passed out at her home, and that's when the ambulance was called to take her to the hospital.To treat the issue, she had an insulin drip but no food.The infusion set had been used for three days.Subsequently, on (b)(6) 2021, she was admitted to the emergency room with blood glucose level of 700 mg/dl and moderate ketones.Moreover, she was stayed in the intensive care unit.During hospitalization, she was administered fluids of saline, insulin, and some unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.Moreover, 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 XC
• Type of Device: UNO INSET I 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14166032
• MDR Text Key: 289730566
• Report Number: 3003442380-2022-00578
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• 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: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001680
• Date Manufacturer Received: 04/12/2022
• Patient Sequence Number: 1