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

Model Number 1001680

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 (b)(6) -year-old female child 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, but the patient went to the emergency room on an unknown date due to high blood glucose level and stayed there for one day.The patient was then transferred to the intensive care unit.She had high ketone levels and the infusion had been used for one day.During hospitalization, she received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment, which resolved the issue.After staying for less than one day in the emergency room and two days in the hospital, on an unknown date, she was released from the hospital with no permanent damage.Previously, within the last year (specific date unknown), she faced two kinked cannula events symptoms/issue noticed three hours after insertion due which she experienced high blood glucose level and had high ketone levels.Therefore, they tried to treat it with bolus via pump and multiple daily doses but was admitted to the emergency room for both events.The infusion had been used for one day and during her stay in the emergency room she received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment.The patient stayed for one day each in the emergency room for both the events.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 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13083365
• MDR Text Key: 283136187
• Report Number: 3003442380-2021-00870
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• 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: 12/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001680
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/16/2021
• Patient Sequence Number: 1