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 came apart close to the site location at all different times which led to high blood glucose levels.The site location was left, and right side of patient's abdomen and the pump was also on the same side in relation to the site location.The infusion had been used for first or second day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, her blood glucose level was between 261-315 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: 15172942
• MDR Text Key: 304612610
• Report Number: 8021545-2022-00158
• 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: 07/28/2022
• Patient Sequence Number: 1