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

Model Number	MMT-378
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2022, it was reported that the patient experienced nausea, vomiting, not feeling good, thirsty, had high blood glucose levels due to a bent cannula.The site location was the patient's abdomen.Consequently, on (b)(6) 2022 at 15:00 hours the patient was admitted to the hospital as the blood glucose level was above 600 mg/dl and experienced diabetic ketoacidosis.During hospitalization, the patient received insulin drip intravenously.Reportedly, on the day of this report (22-feb-2022), the patient was still in the hospital and was admitted in the intensive care unit.Currently, the patient's blood glucose level was 355 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
• Common Device Name: UNO COMFORT 60/17 PCC MINI
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13648810
• Report Number: 8021545-2022-00114
• Device Sequence Number: 17635863
• Product Code: FPA
• UDI-Device Identifier: 05705244008755
• UDI-Public: 05705244008755
• Combination Product (Y/N): Y
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2022

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 Model Number: MMT-378
• Device Lot Number: UNNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2022
• Initial Report FDA Received Date: 03/02/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown