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) 2023 it was reported that the patient faced a bent cannula due to which the patient felt sick/unwell, headache, had diarrhea and experienced high blood glucose level.Therefore, on 13-dec-2022, the patient was admitted to the hospital due to high blood glucose level (1147 mg/dl).Further, the patient stayed for four days in the hospital.At the time of this report, the blood glucose level of the patient was 130 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 was 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: 16383718
• MDR Text Key: 309633985
• Report Number: 3003442380-2023-00158
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MMT-378A
• Device Lot Number: 5391124
• Date Manufacturer Received: 02/03/2023
• Patient Sequence Number: 1