MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 110/9 GREY TCAP 10PK INT

Lot Number 6000963

Device Problem Leak/Splash (1354)

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 leakage at site due to which he experienced high blood glucose level.Therefore, they tried to treat it with bolus via pump, but on (b)(6)2024, the patient first went to the emergency roomand was subsequently hospitalized due to high blood glucose level.Further, the patient was transferred to the intensive care unit.His highest blood glucose level related to incident was 800 mg/dl and kidney damage as reported by the healthcare professional.Moreover, the infusion had been used for three days.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2024, the patient was released from the hospital.No further information was available.

• Brand Name: AUTOSOFT XC
• Type of Device: UNO INSET I 110/9 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19017875
• MDR Text Key: 339082784
• Report Number: 3003442380-2024-00209
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016958
• UDI-Public: 05705244016958
• Combination Product (y/n): N
• 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: 04/02/2024

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: 6000963
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/02/2024
• Patient Sequence Number: 1