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

Lot Number	UNKNOWN
Medical Device Problem Code	Device Handling Problem (3265)
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.It was reported that the soft cannula got dislodged, as the patient had trouble while insertion of the infusion set because of weak eye sight.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT 60/17 PCC
• MDR Report Key: 8481947
• Report Number: 8021545-2019-00117
• Device Sequence Number: 11147476
• Product Code: FPA
• UDI-Device Identifier: 05705244008755
• UDI-Public: 05705244008755
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2019
• Initial Report FDA Received Date: 04/04/2019
• Patient Sequence Number: 1