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

Lot Number UNKNOWN

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 26-mar-2024, it was reported that the patient faced a bent cannula and yesterday ((b)(6) 2024), at 11:00 am, the patient experienced high blood glucose level, vomiting and felt nauseous, which they tried to treat with insulin drip intravenously, but on the same day ((b)(6) 2024), at 12:00 pm, he was admitted to the hospital due to diabetic ketoacidosis with blood glucose level of 829 mg/dl.Moreover, he tested positive for ketone levels (40 ketones in urine).During hospitalization, the patient received insulin drip intravenously and lantus as corrective treatment.At the time of this report, he was still in the hospital.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: 19010088
• MDR Text Key: 338980092
• Report Number: 3003442380-2024-00208
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019553
• UDI-Public: 05705244019553
• Combination Product (y/n): N
• 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: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/01/2024
• Patient Sequence Number: 1