MAUDE Adverse Event Report: SILHOUETTE® PARADIGM®; COMFORT 110/17 PCC

Lot Number	UNKNOWN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event	Malfunction
Event or Problem Description
(b)(4).Event occurred in the united states.The patient reported that the infusion set tubing was coming out of the tugging connector and had high blood glucose level.The location of detachment was at the tubing connector.The site location was at the stomach.The infusion had been in use for 1 day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT 110/17 PCC
• MDR Report Key: 8319392
• Report Number: 8021545-2019-00111
• Device Sequence Number: 1501273
• Product Code: FPA
• UDI-Device Identifier: 05705244009332
• UDI-Public: 05705244009332
• Combination Product (Y/N): N
• PMA/510(K) Number: K162812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial

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 Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 02/08/2019
• Patient Sequence Number: 1