MAUDE Adverse Event Report: SILHOUETTE PARADIGM; UNO COMFORT 110/17 SC1 MINI

Model Number MMT-377A

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.On (b)(6) 2022,it was reported that the patient's infusion set's tubing had detached close to the site location, and it happened in all different times.The site location was patient's left and right side of abdomen, and the pump was located on the same side where the infusion set was inserted.The infusion set had been used for first or second day.Further, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Moreover, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Currently, the patient's blood glucose level was 306 mg/dl.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: UNO COMFORT 110/17 SC1 MINI
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15173586
• MDR Text Key: 304716010
• Report Number: 8021545-2022-00159
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019522
• UDI-Public: 05705244019522
• 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: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MMT-377A
• Device Lot Number: 5374946
• Date Manufacturer Received: 07/29/2022
• Patient Sequence Number: 1