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

Model Number	MMT-377
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 she experienced diabetic ketoacidosis related to an incident where her tubing was leaking as the infusion set's tubing coming apart from the tubing connector.Reportedly, the patient did not go to the hospital, but self-diagnosed the diabetic ketoacidosis.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT 110/17 PCC
• MDR Report Key: 9919498
• Report Number: 8021545-2020-00103
• Device Sequence Number: 3272464
• 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 Model Number: MMT-377
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/03/2020
• Patient Sequence Number: 1