MAUDE Adverse Event Report: SILHOUETTE PARADIGM; UNO COMFORT 80/17 SC1 MINI

Lot Number	5407813
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2023, it was reported that the infusion set's tubing got detached at the tubing connector.The site location was right side of patient's abdomen, and the pump was in the waistband.The infusion had been used for less than a 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.No further information was available.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: UNO COMFORT 80/17 SC1 MINI
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 17639311
• Report Number: 3003442380-2023-00327
• Device Sequence Number: 7936584
• Product Code: FPA
• UDI-Device Identifier: 05705244019676
• UDI-Public: 05705244019676
• Combination Product (Y/N): N
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/01/2025
• Device Lot Number: 5407813
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/29/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown