MAUDE Adverse Event Report: SILHOUETTE PARADIGM; UNO COMFORT 60/17 SC1 MINI

Model Number MMT-378A

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported by the patient that she experienced high blood glucose levels.She stated that she was at a barbecue and she did not have her serter so, she used her hands and when she removed the cannula it did not look right, as it was bent.The infusion set was last changed on (b)(6) 2021.Subsequently, on the same day ((b)(6) 2021 at 06:00 pm), the emergency medical service was dispatched, and she was admitted to the hospital with blood glucose level of more than 600 mg/dl and diabetic ketoacidosis.During hospitalization, she was administered insulin drip intravenously as corrective treatment and saline drip for dehydration intravenously.She was admitted for three days in the hospital.Currently, her blood glucose level was 278 mg/dl.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Type of Device: UNO COMFORT 60/17 SC1 MINI
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 11937017
• MDR Text Key: 254259399
• Report Number: 8021545-2021-00122
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019553
• UDI-Public: 05705244019553
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/01/2023
• Device Model Number: MMT-378A
• Device Lot Number: 5339420
• Date Manufacturer Received: 05/27/2021
• Type of Device Usage: N
• Patient Sequence Number: 1