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 while sleeping, the infusion set's tubing which connects the set to the quick release had come off and the site was disconnected.Reportedly, this was observed when the patient woke up on the morning of this report, felt sick and checked his blood glucose was 346 mg/dl.The site was lower left abdomen and the pump was on his left hip in pajama shorts.The infusion was used since last night.The infusions were stored in a container.The patient was unsure of any stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.The patient changed the set, and his blood glucose came down to 86 mg/dl.No further information available.

• Brand Name: SILHOUETTE® PARADIGM®
• Common Device Name: COMFORT 110/17 PCC
• MDR Report Key: 8468214
• Report Number: 8021545-2019-00116
• Device Sequence Number: 19336582
• 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: 02/09/2017
• Initial Report FDA Received Date: 04/01/2019
• Patient Sequence Number: 1