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

Model Number	MMT-384A
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) 2022, it was reported that the infusion set's tubing was detached from the quick release when the patient disconnected it for taking shower.The site location was right side of patient's abdomen and the pump was in right pocket.Moreover, the infusion set was used for less than 24 hours.Reportedly, the infusion sets were not used in a place where they might have been exposed to extreme temperatures and humidity, nor was there any stress or pull on the tubing.The pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 188 mg/dl.Further, complaint investigation was performed on the returned used device (1 tubing), it was found that the tubing was detached because it was not properly assembled to the connector.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: 15443874
• Report Number: 8021545-2022-00172
• Device Sequence Number: 4621951
• Product Code: FPA
• UDI-Device Identifier: 05705244019676
• UDI-Public: 05705244019676
• Combination Product (Y/N): Y
• 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): 09/19/2022

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: 08/01/2024
• Device Model Number: MMT-384A
• Device Lot Number: 5364901
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 09/19/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown