MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/6 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 united states it was reported that a 18-years-old female patient faced a bent cannula due to which she experienced high blood glucose level.Therefore, they tried to treat it with bolus via pump and multiple daily injection before she felt sick, but on (b)(6) 2023, she first went to the emergency room and was subsequently hospitalized due to high blood glucose level.Her highest blood glucose level was in the 600s mg/dl.Moreover, the infusion had been used for two days.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2023/ on (b)(6) 2023 (the patient was unsure), she was released from the hospital with no permanent damage.Moreover, this similar issue occurred on (b)(6) 2023 as 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 (b)(6) 2023, she first went to the emergency room and was subsequently hospitalized due to high blood glucose level.Her highest blood glucose level ranged between 400-500 mg/dl and had moderate or high ketone.Moreover, the infusion had been used for four days.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.On (b)(6) 2023, it was reported that since june-2020, the patient faced 10 kinked cannulas with similar types of cannulas within 3 or more hours after insertion.The patient's blood glucose level at the time of incident was 300 mg/dl.Moreover, the infusion had been used for couple of hours for some and 2-4 days for others and the site location was patient's abdomen or upper buttocks.Further, the patient 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 was 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: 18455254
• MDR Text Key: 332262695
• Report Number: 3003442380-2024-00110
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/05/2024
• Patient Sequence Number: 1