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

Lot Number UNKNOWN

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 (b)(6).It was reported that on (b)(6) 2023, the patient faced a bent cannula due to which she experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection, but on the same day ((b)(6) 2023), the patient went to the emergency room and was subsequently hospitalized due to high blood glucose.Her highest blood glucose level ranged between 500-600 mg/dl and had high ketone level which the healthcare professional assessed as dangerous/life threatening.Moreover, the infusion had been used for less than one day.Further, the patient was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.On (b)(6) 2022, she was released from the hospital.Furthermore, the patient again experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection, but on the next day of release ((b)(6) 2023), the patient again went to the emergency room where they noticed a bent cannula when they removed the infusion set and was subsequently hospitalized due to high blood glucose.Her highest blood glucose level was above 500 mg/dl and had high ketone level which the healthcare professional assessed as dangerous/life threatening.Moreover, the infusion had been used for less than one day and the site location was her abdomen.Further, the patient was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment 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: 18490310
• MDR Text Key: 332603621
• Report Number: 3003442380-2024-00117
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/02/2024
• Patient Sequence Number: 1