MAUDE Adverse Event Report: SILHOUETTE PARADIGM; UNO COMFORT SHORT 46/13 PCC MCNI

Model Number	MMT-368600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, it was reported that while sleeping, the patient experienced high blood glucose level of 24 mmol/dl due to infusion set's tubing which was detached at the end of tubing where it was attached to the site.The site location was patient's abdomen and the pump was located at right hand side.Moreover, the infusion had been used since last night.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 21.4 mmol/l.No further information available.
Event or Problem Description
On 02-jul-2021: follow up information was submitted to update the awareness date.Moreover, the result of the (complaint investigation) visual inspection performed on the returned unused device (1 used set) and a connector test, showed that it was possible to detach the tubing connector from the cannula part without activating the quick release function.Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2021, it was reported that while sleeping, the patient experienced high blood glucose level of 24 mmol/dl due to infusion set's tubing which was detached at the end of tubing where it was attached to the site.The site location was patient's abdomen and the pump was located at right hand side.Moreover, the infusion had been used since last night.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.Currently, the patient's blood glucose level was 21.4 mmol/l.No further information available.

• Brand Name: SILHOUETTE PARADIGM
• Common Device Name: UNO COMFORT SHORT 46/13 PCC MCNI
• MDR Report Key: 11677230
• Report Number: 8021545-2021-00109
• Device Sequence Number: 3617459
• Product Code: FPA
• UDI-Device Identifier: 05705244008410
• UDI-Public: 05705244008410
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: MMT-368600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 07/02/2021
• Patient Sequence Number: 1