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

Model Number 1001680

Device Problem Material Deformation (2976)

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 male child patient's infusion set's tubing kinked due to which the patient experienced high blood glucose level.Therefore, they tried to treat it with bolus via the pump, but on (b)(6) 2021, the patient went to the emergency room.The patient's highest blood glucose level was over 500 mg/dl and had high ketone levels which was assessed as dangerous/life threatening by the healthcare professional.The infusion had been used for two days.While in the emergency room, the patient received fluids of saline, insulin and unspecified medication (drug name unknown) intravenously as corrective treatment, which resolved the issue.After staying for eight hours in the emergency room (on the same day), the patient was released with no permanent damage.Moreover, between (b)(6) 2021 and (b)(6) 2021, the patient faced damage to the infusion set line, after insertion.The infusion had been used for two days.Moreover, they replaced the infusion set and insulin was resumed successfully.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: 13123102
• MDR Text Key: 283136955
• Report Number: 3003442380-2021-00880
• 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: 12/31/2021

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 Model Number: 1001680
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/21/2021
• Initial Date FDA Received: 12/30/2021
• Patient Sequence Number: 1