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

Lot Number 5335046

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 (b)(6).On (b)(6) 2021, it was reported that the patient's infusion set's tubing came out while he was celebrating his birthday.Reportedly, his blood glucose level kept going up (20-22 mmol/l).Therefore, he changed it and his blood glucose went down.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: 12671063
• MDR Text Key: 277888333
• Report Number: 8021545-2021-00160
• 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
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2023
• Device Lot Number: 5335046
• Date Manufacturer Received: 10/12/2021
• Type of Device Usage: N
• Patient Sequence Number: 1