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

Lot Number 6002568

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 10-years-old male child patient faced a bent cannula due to which he experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection, but on (b)(6) 2024, the patient went to emergency room due to high blood glucose level.His highest blood glucose level related to incident was 505 mg/dl and he had high ketone level which healthcare professional assessed as dangerous or life-threatening.During hospitalization, the patient received carbohydrates which resolved the issue.On (b)(6) 2024, the patient was released from the hospital with no permanent damage.Moreover, this similar issue occurred with three similar types of infusion sets (event one was week ago and events two and three were on (b)(6) 2024) and the site location was patient's abdomen.Furthermore, the cannula was bent and there was bleeding at the site.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: 19017970
• MDR Text Key: 339082731
• Report Number: 3003442380-2024-00212
• 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: 04/02/2024

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: 6002568
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/02/2024
• Patient Sequence Number: 1