MAUDE Adverse Event Report: VARISOFT; UNO COMFORT SHORT 60/13 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 (b)(6).It was reported that the patient faced a possible occlusion in the tubing unreported at that time which led to high blood glucose level.Therefore, she tried to treat it with bolus via pump, but on (b)(6) 2023, she first went to the emergency room and was subsequently hospitalized due to high blood glucose level.The patient's highest blood glucose level related to the incident was 830 mg/dl and had high ketone level which the healthcare professional assessed as dangerous/life-threatening.During hospitalization, the patient received fluids of saline (unknown), 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 was available.

• Brand Name: VARISOFT
• Type of Device: UNO COMFORT SHORT 60/13 TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18433799
• MDR Text Key: 331789069
• Report Number: 8021545-2024-00100
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018693
• UDI-Public: 05705244018693
• Combination Product (y/n): Y
• PMA/PMN Number: K162812
• 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: 01/03/2024
• Patient Sequence Number: 1