MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/9 GREY TCAP 10PK INT

Model Number 1001681

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 changed her infusion site out before going to bed and went to sleep.Therefore, she woke up with high blood glucose level and when she took off her site, the cannula was bent after three or more hours of insertion.They tried to treat high blood glucose level with correction injection via multiple daily injection, but on (b)(6) 2022, the patient went to the emergency room and was subsequently hospitalized (after staying for 24 hours in the emergency room) due high blood glucose level.Her highest blood glucose level was 1051 mg/dl and had high ketone level which her healthcare professional assessed as dangerous/life threatening.Moreover, the site location was patient's abdomen and the infusion set had been used for 2 days.Further, she was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously which resolved the issue.On (b)(6) 2022, she 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 60/9 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15481785
• MDR Text Key: 300582414
• Report Number: 3003442380-2022-01035
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016651
• UDI-Public: 05705244016651
• 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: 09/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001681
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/13/2022
• Patient Sequence Number: 1