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 faced a bent cannula and experienced high blood glucose level.Therefore, they tried to treat it with a bolus via pump, multiple daily injection and changed the infusion set, but on (b)(6) 2022/(b)(6) 2022, the patient went to the emergency room and was subsequently hospitalized due to high blood glucose level.His highest blood glucose level was 1670 mg/dl and had high ketone level.Moreover, the patient had a throat injury, not sure what it was but will be getting an endoscopy to find out and he also developed a blister that requires wound treatment.The infusion had been used for 1-2 days.Further, she was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin, antibiotics and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.On (b)(6) 2022, he was released from the hospital.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: 15517602
• MDR Text Key: 300915824
• Report Number: 3003442380-2022-01047
• 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: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• 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: 09/21/2022
• Patient Sequence Number: 1