MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/9 GREY TCAP 10PK INT

Lot Number UNKNOWN

Device Problem Infusion or Flow Problem (2964)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient reported that she received an occlusion alarm from her pump.Therefore, on 08-nov-2023 (wednesday), the patient was picked up by the ambulance and admitted her to the hospital due to high blood glucose level and upper respiratory infection.Her highest blood glucose level was 964 mg/dl and she had high ketone level which was assessed as dangerous/life-threatening by the healthcare professional.Moreover, the infusion set had been used for two days.Further, the patient was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, potassium, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.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: 18432886
• MDR Text Key: 331866665
• Report Number: 3003442380-2024-00100
• 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: 01/03/2024

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: UNKNOWN
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/02/2024
• Patient Sequence Number: 1