MAUDE Adverse Event Report: SILHOUETTE PARADIGM; UNO COMFORT SHORT 60/13 SC1 MCNI

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2022, the patient's mother reported that the patient's infusion set's tubing detached at the quick release connector while sleeping, which led to high blood glucose level.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: UNO COMFORT SHORT 60/13 SC1 MCNI
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15049438
• MDR Text Key: 296137134
• Report Number: 8021545-2022-00156
• Device Sequence Number: 1
• Product Code: FPA
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/05/2022
• Patient Sequence Number: 1