MAUDE Adverse Event Report: VARISOFT; UNO COMFORT SHORT 80/13 TCAP 10PK INT

Model Number 1002828

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number: (b)(4).Event occurred in the united states.The patient reported that on (b)(6) 2023, (b)(6) 2023, (b)(6) 2023 and (b)(6) 2023, the infusion set's tubing detached from the connector and this issue occurred with four infusion sets.Therefore, the patient's blood glucose level ranged between 300-500 mg/dl at the time of these events.Moreover, the infusion set had been used for 1-2 day for all the events.Further, they replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: VARISOFT
• Type of Device: UNO COMFORT SHORT 80/13 TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16451197
• MDR Text Key: 310330606
• Report Number: 8021545-2023-00131
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018723
• UDI-Public: 05705244018723
• 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: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002828
• Device Lot Number: 5388376
• Date Manufacturer Received: 02/21/2023
• Patient Sequence Number: 1