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

Lot Number 6002261

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's mother that her 12-years-old daughter faced a bent cannula which led to high blood glucose level on (b)(6) 2024.Reportedly, her daughter was not feeling well (dizziness, nausea) and flu/illness.They tried to treat it with bolus via pump, but on the same day ((b)(6) 2023), she first went to the emergency room and was subsequently hospitalized due to diabetic ketoacidosis.Her highest blood glucose level was over 400 mg/dl and had high ketone level which her healthcare professional assessed as dangerous or life-threatening.Moreover, the issue occurred with one infusion set used for three days (within labeling), and site location was patient's abdomen.During hospitalization, the patient received fluids of saline (unknown), insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2024, 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 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: 18976676
• MDR Text Key: 338549243
• Report Number: 3003442380-2024-00200
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 6002261
• Date Manufacturer Received: 03/18/2024
• Patient Sequence Number: 1