MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 110/6 GREY TCAP 10PK INT

Model Number 1001728

Device Problem Loss of or Failure to Bond (1068)

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 an issue with the infusion set as it fell out during use, and he could not realize that the insulin was not being delivered due which he experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection.On (b)(6) 2023, the patient went to the emergency room due to high blood glucose level.His highest blood glucose level was 800 mg/dl.Moreover, the infusion had been used for 3 days.While in the emergency room, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.Further, the patient faced the similar issue as the infusion set cannula fell out due to which, again he experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection.On (b)(6) 2023, the patient went to the emergency room and was subsequently hospitalized due to high blood glucose level.His highest blood glucose level was 1100 mg/dl.Moreover, the infusion had been used for 3 days.Further, the patient was transferred to the intensive care unit.While in the hospital, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.At the time of this report, the patient was not released from the hospital.No further information available.

• Brand Name: AUTOSOFT XC
• Type of Device: UNO INSET I 110/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16330855
• MDR Text Key: 309130805
• Report Number: 3003442380-2023-00149
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016927
• UDI-Public: 05705244016927
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001728
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 01/31/2023
• Patient Sequence Number: 1